DDrare: Database of Drug Development for Rare Diseases

Searched query = "Polycystic kidney disease", "PKD", "PCKD", "Polycystic kidney", "ADPKD", "ARPKD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 15 or 45 mg; 30 or 60 mg; 30 or 90 mg; AL; AMIAS; AMLODIPINE; APRINOX; Acetate; Amias; Aminohippurate; Aminohippurate Sodium Inj 20%; Amlodipine; Anti-hypertensive medications; Antihypertensive drugs; Aprinox; Arginine; BARDOXOLONE METHYL; BENDROFLUMETHIAZIDE; BIM 23014; BISOPROLOL; BOSUTINIB; Bardoxolone; Bardoxolone Methyl; Bardoxolone methyl; Bardoxolone methyl 10 mg; Bardoxolone methyl 15 mg; Bardoxolone methyl 20 mg; Bardoxolone methyl 5 mg; Bardoxolone methyl capsules; Bardoxolone methyl oral capsule; Behavioral: Diet and water adjustment; Bendroflumethiazide; Bisoprolol; Bosutinib; Bosutinib (anhydrous); C03XA01; CANDESARTAN; CARDURA; Calcineurin inhibitors maintenance; Candesartan; Candesartan and Cilnidipine; Candesartan plus non-CCB agents; Certican; Certican Tabletten; Cilnidipine; Conventional therapy; Curcumin; DOXAZOSIN; Doxazosin; Emodin; Equal; Everolimus; G1117337; GENZ-682452; GLPG2737; GZ402671; Genz-682452-AU; HCT; High water intake; Hydralazine; Hydrochlorothiazide; ISTIN; Imidapril; Intravenous injection autologous mesenchymal stem cells; Iohexol; Iohexol Inj 300 milligrams per milliliter (MG/ML); Istin; JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG); JINARC - 15 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE; JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG); JINARC - 30 MG +90 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 90 MG); JINARC - 30 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE; Jinarc; Jinarc - Tolvaptan tablets; Jinarc 15 mg tablets, Jinarc 45 mg tablets; Jinarc 30 mg tablets, 90 mg tablets; Jinarc 30 mg tablets, Jinarc 60 mg tablets; Jinarc® 15mg Tablet; Jinarc® 30 Tablet; KD019 (tesevatinib); LANREOTIDE ACETATE; LISINOPRIL; Lanreotide; Lisinopril; Lixivaptan; Long-acting somatostatin; Losartan; METFORMIN; METFORMINA; MONOCOR; Metformin; Metformina; Monocor; NG-Monomethyl-L-arginine; Ng-monomethyl-L-arginine (drug); Niacinamide; OPC-41061; OPC-41061 (tolvaptan); Octeotride; Octreotide; Octreotide LAR; Octreotide-LAR; Other: Ad libitum water intake; Other: High Water Intake; Other: Low Blood Pressure Control; Other: Saline solution; Other: Saline solution.; Other: Standard; Other: Standard Blood Pressure Control; Other: Water; Other: Water prescription; Other: water; PF-05208763; Pasireotide; Pasireotide LAR; Pioglitazone; Placebo; Potassium; Pravastatin; Procedure: renal sympathetic denervation; Protein; RAD001; RAPAMUNE*100CPR RIV 1MG; RAPAMUNE*30CPR RIV 1MG; RAPAMUNE*30CPR RIV 2MG; RGLS4326; RTA 402; Radiation: PET/CT Scan; Ramipril; Rapamune; Rapamune 1mg tablets; Rapamycin; SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI; SANDOSTATINA LAR; SAR402671, GZ402671 or GZ/SAR402671; SIROLIMUS; SKI-606; Saline; Samsca; Samsca 15 mg tablets; Samsca 30 mg tablets; Sandostatin LAR; Sandostatina; Sandostatina LAR; Sandostatina Lar IM Fl 20mg +2F; Sirolimus; Sodium citrate; Sodiumchloride; Somatostatin; Somatuline; Somatuline Autogel; Somatuline Autosolution; Spironolactone; Sugar pill; TOLVAPTAN; TOLVAPTAN (OPC-41061); TOLVAPTAN 15; TOLVAPTAN 30; TOLVAPTAN 45/15; TOLVAPTAN 60/30; Telmisartan; Tesevatinib; Tetracosactin; Tolvaptan; Tolvaptan (OPC-41061); Tolvaptan 15 mg Tablet; Tolvaptan 15 mg tablets; Tolvaptan 15mg; Tolvaptan 30 mg Tablet; Tolvaptan 30 mg tablets; Tolvaptan 30mg; Tolvaptan 7.5 mg Tablet; Tolvaptan IR; Tolvaptan MR; Tripterygium; Tripterygium Wilfordii; Tripterygium wilfordii; Triptolide; Triptolide-Containing Formulation; UDCA; URSOCHOL 300; Unknown; Ursochol; Ursodeoxycholic Acid; Ursodeoxycholic acid; Venglustat; Venglustat GZ/SAR402671; Venglustat GZ402671; Water; ZESTRIL; ZUGLIMET - 500 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/AL; [METFORMINA]; [TOL; [TOLVAPTAN 15]; [TOLVAPTAN 30]; [TOLVAPTAN 45/15]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2010-023017-65-BG (EUCTR)	14/05/2012	22/05/2012	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
2	EUCTR2010-023017-65-LT (EUCTR)	14/11/2011	02/09/2011	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden
3	EUCTR2010-023017-65-IT (EUCTR)	28/10/2011	14/03/2012	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF 05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: BOSUTINIB Other descriptive name: SKI-606	PFIZER INC.	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Australia;Japan;Sweden
4	EUCTR2010-023017-65-GB (EUCTR)	02/08/2011	08/04/2011	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Japan;Sweden
5	EUCTR2010-023017-65-CZ (EUCTR)	16/06/2011	01/02/2011	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Japan;Moldova, Republic of;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2010-023017-65-HU (EUCTR)	27/05/2011	05/04/2011	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Germany;Japan;Moldova, Republic of;Sweden
7	EUCTR2010-023017-65-SK (EUCTR)	25/05/2011	28/04/2011	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
8	EUCTR2010-023017-65-PL (EUCTR)	21/04/2011	12/04/2011	A multicenter, randomized, double-blind, placebo-controlled study of thesafety, effectiveness, and pharmacokinetics of bosutinib versus placebo insubjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	Hungary;Czech Republic;Slovakia;Spain;Poland;Lithuania;Italy;United Kingdom;Sweden
9	EUCTR2010-023017-65-ES (EUCTR)	18/03/2011	27/01/2011	ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).	ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).	Poliquistosis renal autosómica dominante (PRAD). MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	PFIZER, S.L.U.	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden
10	EUCTR2010-023017-65-SE (EUCTR)	17/03/2011	20/01/2011	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT01233869 (ClinicalTrials.gov)	December 2010	28/10/2010	Bosutinib For Autosomal Dominant Polycystic Kidney Disease	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)	Polycystic Kidney, Autosomal Dominant	Drug: Bosutinib;Drug: Placebo	Pfizer	NULL	Completed	18 Years	50 Years	All	172	Phase 2	United States;Australia;Canada;Czech Republic;Hungary;Italy;Korea, Republic of;Lithuania;Moldova, Republic of;Poland;Romania;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-023017-65-BG
(EUCTR)

14/05/2012

22/05/2012

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden

EUCTR2010-023017-65-LT
(EUCTR)

14/11/2011

02/09/2011

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden

EUCTR2010-023017-65-IT
(EUCTR)

28/10/2011

14/03/2012

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF 05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: BOSUTINIB
Other descriptive name: SKI-606

PFIZER INC.

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Australia;Japan;Sweden

EUCTR2010-023017-65-GB
(EUCTR)

02/08/2011

08/04/2011

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Japan;Sweden

EUCTR2010-023017-65-CZ
(EUCTR)

16/06/2011

01/02/2011

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Japan;Moldova, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-023017-65-HU
(EUCTR)

27/05/2011

05/04/2011

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Germany;Japan;Moldova, Republic of;Sweden

EUCTR2010-023017-65-SK
(EUCTR)

25/05/2011

28/04/2011

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

EUCTR2010-023017-65-PL
(EUCTR)

21/04/2011

12/04/2011

A multicenter, randomized, double-blind, placebo-controlled study of thesafety, effectiveness, and pharmacokinetics of bosutinib versus placebo insubjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

Hungary;Czech Republic;Slovakia;Spain;Poland;Lithuania;Italy;United Kingdom;Sweden

EUCTR2010-023017-65-ES
(EUCTR)

18/03/2011

27/01/2011

ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).

Poliquistosis renal autosómica dominante (PRAD).
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

PFIZER, S.L.U.

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden

EUCTR2010-023017-65-SE
(EUCTR)

17/03/2011

20/01/2011

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01233869
(ClinicalTrials.gov)

December 2010

28/10/2010

Bosutinib For Autosomal Dominant Polycystic Kidney Disease

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Polycystic Kidney, Autosomal Dominant

Drug: Bosutinib;Drug: Placebo

Pfizer

NULL

Completed

18 Years

50 Years

All

172

Phase 2

United States;Australia;Canada;Czech Republic;Hungary;Italy;Korea, Republic of;Lithuania;Moldova, Republic of;Poland;Romania;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom