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CCB Safety Study in Treatment of Hypertension of ADPKD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Kyorin University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Kyorin University
ClinicalTrials.gov Identifier:
NCT00541853
First received: October 9, 2007
Last updated: October 17, 2007
Last verified: October 2007
History of Changes
  Purpose

This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.


Condition Intervention Phase
Kidney, Polycystic, Autosomal Dominant
 Drug: Candesartan
Drug: Candesartan and Cilnidipine
Drug: Candesartan plus non-CCB agents
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyorin University:

Primary Outcome Measures:
  • Kidney Volume measured by MRI. [ Time Frame: Every year ]

Secondary Outcome Measures:
  • Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: any time during study period ]
Estimated Enrollment: 150
Study Start Date: December 2007
Estimated Study Completion Date: November 2012
Arms Assigned Interventions
Active Comparator: A
ADPKD patients with blood pressure above 130/85 are enrolled. The patients whose blood pressure is controlled under 130/85 by Candesartan alone are classified into group A.
 Drug: Candesartan
Candesartan upto 8mg
Experimental: B
The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group B, blood pressure is controlled by Candesartan plus Cilnidipine. If blood pressure is not lowered by Candesartan plus Cilnidipine alone, another antihypertensive agents except CCB and ACEI are allowable.
 Drug: Candesartan and Cilnidipine
Candesartan upto 8mg per day and Cilnidipine upto 20mg per day
Active Comparator: C
The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group C, blood pressure is controlled by Candesartan plus non-CCB agents such as beta- or alpha- adrenergic blockers or another ARB. Any CCB and ACEI are not allowable.
 Drug: Candesartan plus non-CCB agents
Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI

  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 130/85 mmHg.
  • Age between 20 and 60 years old.
  • Plasma creatinine less than 2.0mg in man and 1.5mg in woman.
  • 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: NCT00541853

Contacts
Contact: Eiji Higashihara, M.D. +81-422-47-5511 ext 5813 ehigashi@kyorin-u.ac.jp

Locations
Japan
Kyorin University School of Medicine Not yet recruiting
Mitaka, Tokyo, Japan, 181-8611
Contact: Eiji Higashihara, M.D.    81+422475511 ext 5813    ehigashi@kyorin-u.ac.jp   
Contact: Kikuo Nutahara, M.D.    81-422475511 ext 5815    kinuta@kyorin-u.ac.jp   
Department of Urology, National Hospital Organaization Chiba-East Hospital Not yet recruiting
Chiba, Chiba, Japan, 260-8712
Contact: Koichi Kamura, MD    81+432615171 ext 7607    kamura@cehpnet.com   
Toranomon Hospital Kajigaya, Kidney center Not yet recruiting
Kanagawa, Japan, 213-8587
Contact: Yoshifumi Ubara, MD    81+448775111 ext 6064    ubara@toranomon.gr.jp   
Department of Urology, Teikyo University, School of Medicine Not yet recruiting
Tokyo, Japan, 173-8605
Contact: Shigeo Horie, MD    81+339641211    shorie@med.teikyo-u.ac.jp   
Contact: Satoru Muto, MD    81+33964-1211    muto@med.teikyo-u.ac.jp   
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine Not yet recruiting
Tokyo, Japan, 105-8471
Contact: Tatsuo Hosoya, MD    81+334331111 ext 3220    t-hosoya@jikei.ac.jp   
Contact: Kazushige Hanaoka, MD    81+334331111 ext 3221    khanaoka@jikei.ac.jp   
Toranomon Hospital, Kidney center Not yet recruiting
Tokyo, Japan, 105-8470
Contact: Kenmei Tkaichi, MD    81+335881111 ext 7065    takaichi@toranomon.gr.jp   
Sponsors and Collaborators
Kyorin University
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Eiji Higashihara, M.D. Kyorin University, School of Medicine
  More Information

No publications provided by Kyorin University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00541853     History of Changes
Other Study ID Numbers: ADPKDCCB
Study First Received: October 9, 2007
Last Updated: October 17, 2007
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin University:
Autosomal Dominant Polycystic Kidney Disease
Hypertension
Angiotensin-2 Receptor Blocker
Calcium Channel Blocker
Kidney Volume

Additional relevant MeSH terms:
Polycystic Kidney, Autosomal Dominant
Kidney Diseases
Kidney Diseases, Cystic
Polycystic Kidney Diseases
Urologic Diseases
Candesartan
Candesartan cilexetil
Cilnidipine
Angiotensin II Type 1 Receptor Blockers
 Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015