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	NCT03541447 (ClinicalTrials.gov)	December 12, 2018	17/5/2018	Tolvaptan-Octreotide LAR Combination in ADPKD	A Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration	Autosomal Dominant Polycystic Kidney Disease	Drug: Tolvaptan;Drug: Octreotide LAR;Other: Placebo	Mario Negri Institute for Pharmacological Research	Otsuka Pharmaceutical Italy S.r.l.	Recruiting	18 Years	N/A	All	20	Phase 2	Italy
2	EUCTR2017-004701-40-IT (EUCTR)	06/08/2018	26/09/2019	STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION	A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION - Tolvaptan-Octreotide combination in ADPKD	Autosomal Dominant Policiytic Kidney Disease 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]		IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Italy
3	NCT01377246 (ClinicalTrials.gov)	May 2011	20/6/2011	Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency	A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFECTS OF LONG-ACTING SOMATOSTATIN (OCTREOTIDE LAR) THERAPY ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE TO SEVERE RENAL INSUFFICIENCY	Autosomal Dominant Polycystic Kidney Disease	Drug: Octreotide -LAR;Other: Saline solution.	Mario Negri Institute for Pharmacological Research	NULL	Completed	18 Years	75 Years	All	100	Phase 3	Italy
4	EUCTR2011-000138-12-IT (EUCTR)	04/04/2011	28/12/2011	A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2	A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2	Autosomal Dominant Polycystic Kidney Disease MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders		IST. DI RICERCHE FARMACOLOG. M. NEGRI	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 3	Italy
5	NCT00426153 (ClinicalTrials.gov)	January 2007	22/1/2007	Octreotide in Severe Polycystic Liver Disease	Pilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver Disease	Polycystic Kidney, Autosomal Dominant;Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Kidney, Polycystic;Abdominal Pain	Drug: Octreotide;Drug: Placebo	Mayo Clinic	Novartis;National Center for Research Resources (NCRR)	Completed	18 Years	80 Years	All	42	Phase 2;Phase 3	United States

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

NCT03541447
(ClinicalTrials.gov)

December 12, 2018

17/5/2018

Tolvaptan-Octreotide LAR Combination in ADPKD

A Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration

Autosomal Dominant Polycystic Kidney Disease

Drug: Tolvaptan;Drug: Octreotide LAR;Other: Placebo

Mario Negri Institute for Pharmacological Research

Otsuka Pharmaceutical Italy S.r.l.

Recruiting

18 Years

N/A

All

Phase 2

Italy

EUCTR2017-004701-40-IT
(EUCTR)

06/08/2018

26/09/2019

STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION

A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION - Tolvaptan-Octreotide combination in ADPKD

Autosomal Dominant Policiytic Kidney Disease
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]

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Italy

NCT01377246
(ClinicalTrials.gov)

May 2011

20/6/2011

Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency

A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFECTS OF LONG-ACTING SOMATOSTATIN (OCTREOTIDE LAR) THERAPY ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE TO SEVERE RENAL INSUFFICIENCY

Autosomal Dominant Polycystic Kidney Disease

Drug: Octreotide -LAR;Other: Saline solution.

Mario Negri Institute for Pharmacological Research

NULL

Completed

18 Years

75 Years

All

100

Phase 3

Italy

EUCTR2011-000138-12-IT
(EUCTR)

04/04/2011

28/12/2011

A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2

Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders

IST. DI RICERCHE FARMACOLOG. M. NEGRI

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Italy

NCT00426153
(ClinicalTrials.gov)

January 2007

22/1/2007

Octreotide in Severe Polycystic Liver Disease

Pilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver Disease

Polycystic Kidney, Autosomal Dominant;Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Kidney, Polycystic;Abdominal Pain

Drug: Octreotide;Drug: Placebo

Mayo Clinic

Novartis;National Center for Research Resources (NCRR)

Completed

18 Years

80 Years

All

Phase 2;Phase 3

United States