Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT00890279
First received: April 28, 2009
Last updated: December 1, 2009
Last verified: December 2009
  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: Cilnidipine
Drug: Imidapril
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB

Resource links provided by NLM:


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: July 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cilnidipine
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: Cilnidipine
Cilnidipine up to 20 mg
Other Name: ATELEC
Active Comparator: Imidapril
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: Imidapril
Imidapril up to 10 mg per day
Other Name: TANATRIL

Detailed Description:
Maximum dosage of candesartan is 8 mg/day. Dosage of imidapril is in the range of 2.5-10 mg/day. Dosage of cilnidipine is in the range of 5-20mg/day.
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Department of Medicine II, Hokkaido Univserity School of Medicine
Sapporo, Hokkaido, Japan, 0608638
Toranomon Hospital Kajigaya, Kidney center
Kawasaki, Kanagawa, Japan, 2138587
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
Toranomon Hospital, Kidney center
Minato-ku, Tokyo, Japan, 1058470
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
Minato-ku, Tokyo, Japan, 1058471
Department of Urology, Kyorin University School of Medicine
Mitaka, Tokyo, Japan, 1818611
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
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Shigeo Horie, MD Teikyo University
  More Information

Responsible Party: Shigeo Horie, M.D./Chairman of the Department of Urology at Teikyo University, Teikyo University, School of Medicine
ClinicalTrials.gov Identifier: NCT00890279     History of Changes
Other Study ID Numbers: ADPKDhypertension 
Study First Received: April 28, 2009
Last Updated: December 1, 2009
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

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Kidney Diseases, Cystic
Imidapril
Angiotensin-Converting Enzyme Inhibitors
Cilnidipine
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on December 09, 2016