Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

This study is not yet open for participant recruitment.

Verified by Ministry of Health, Labour and Welfare, Japan, April 2009

First Received: April 28, 2009 No Changes Posted

Sponsors and Collaborators:	Ministry of Health, Labour and Welfare, Japan Japanese Ministry of Health, Labor and Welfare
Information provided by:	Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:	NCT00890279

Purpose

This phase II study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB) alone.

Condition	Intervention	Phase
Kidney, Polycystic, Autosomal Dominant	Drug: Candesartan Drug: Cilnidipine Drug: Imidapril	Phase II

Genetics Home Reference related topics: polycystic kidney disease

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Imidapril Imidapril hydrochloride Cilnidipine CV 11974 Candesartan cilexetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB

Further study details as provided by Ministry of Health, Labour and Welfare, Japan:

Primary Outcome Measures:

eGFR [ Time Frame: every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Kidney Volume measured by MRI [ Time Frame: every 3 months to every 2 years ] [ Designated as safety issue: No ]
Serum creatinine level [ Time Frame: every 3 months to every 2 years ] [ Designated as safety issue: No ]
Induction of hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: every 3 months to every 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	May 2009
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cilnidipine: Experimental The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group A, blood pressure is controlled by Candesartan plus Cilnidipine.	Drug: Candesartan Candesartan up to 8 mg per day Drug: Cilnidipine Cilnidipine up to 20 mg
Imidapril: Active Comparator The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group B, blood pressure is controlled by Candesartan plus Imidapril.	Drug: Candesartan Candesartan up to 8 mg per day Drug: Imidapril Imidapril up to 10 mg per day

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ADPKD patients
Blood pressure measured at out-patient setting is above 120/80 mmHg
Age between 20 and 60 years old
eGFR more than 30 ml/min/1.73m2
Patients give informed consent

Exclusion Criteria:

Patients with severe cardiovascular and hepatic disorders
Patients with complications of central nervous vascular disorders
Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
Patients currently engaging in other experimental protocol
Patients with intracranial aneurysma
Patients who must use diuretics
Allergic patients to Candesartan or Cilnidipine
Patients whose hypertension is not controlled by medication of this protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890279

Contacts

Contact: Shigeo Horie, MD	+81339642497	shorie@med.teikyo-u.ac.jp
Contact: Satoru Muto, MD, PhD	+81339642497	muto@med.teikyo-u.ac.jp

Locations

Japan
Department of Urology, National Hospital Organaization Chiba-East Hospital
Chiba, Japan, 2608712
Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences
Niigata, Japan, 9518510
Japan, Hokkaido
Department of Medicine II, Hokkaido Univserity School of Medicine
Sapporo, Hokkaido, Japan, 0608638
Japan, Kanagawa
Toranomon Hospital Kajigaya, Kidney center
Kawasaki, Kanagawa, Japan, 2138587
Japan, Tokyo
Department of Urology, Kyorin University School of Medicine
Mitaka, Tokyo, Japan, 1818611
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
Minato-ku, Tokyo, Japan, 1058471
Toranomon Hospital, Kidney center
Minato-ku, Tokyo, Japan, 1058470
Department of Medicine II, Nippon Medical School
Bunkyo-ku, Tokyo, Japan, 1138602
Department of Urology, Teikyo University School of Medicine
Itabashi-ku, Tokyo, Japan, 1738605

Sponsors and Collaborators

Ministry of Health, Labour and Welfare, Japan

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Shigeo Horie, MD

Teikyo University

More Information

No publications provided

Responsible Party:	Teikyo University, School of Medicine ( Shigeo Horie, M.D./Chairman of the Department of Urology at Teikyo University )
Study ID Numbers:	ADPKDhypertension
Study First Received:	April 28, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00890279 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ministry of Health, Labour and Welfare, Japan:

Autosomal Dominant Polycystic Kidney Disease
Hypertension
Angiotensin-II Receptor Blocker
Calcium Channel Blocker

Angiotensin converting enzyme inhibitor
Kidney Volume
eGFR

Study placed in the following topic categories:

Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Polycystic Kidney Diseases
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers

Candesartan cilexetil
Cilnidipine
Calcium, Dietary
Urologic Diseases
Imidapril
Candesartan
Angiotensin-Converting Enzyme Inhibitors
Kidney Diseases
Hypertension
Autosomal Dominant Polycystic Kidney Disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Polycystic Kidney Diseases
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers

Membrane Transport Modulators
Cilnidipine
Candesartan cilexetil
Urologic Diseases
Therapeutic Uses
Imidapril
Candesartan
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Kidney Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009