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CCB Safety Study in Treatment of Hypertension of ADPKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00541853
Recruitment Status : Unknown
Verified October 2007 by Kyorin University.
Recruitment status was:  Not yet recruiting
First Posted : October 10, 2007
Last Update Posted : October 18, 2007
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Kyorin University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Kidney, Polycystic, Autosomal Dominant Drug: Candesartan Drug: Candesartan and Cilnidipine Drug: Candesartan plus non-CCB agents Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2007
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: any time during study period ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541853


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

Locations
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Japan
Kyorin University School of Medicine
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
Chiba, Chiba, Japan, 260-8712
Contact: Koichi Kamura, MD    81+432615171 ext 7607    kamura@cehpnet.com   
Toranomon Hospital Kajigaya, Kidney center
Kanagawa, Japan, 213-8587
Contact: Yoshifumi Ubara, MD    81+448775111 ext 6064    ubara@toranomon.gr.jp   
Toranomon Hospital, Kidney center
Tokyo, Japan, 105-8470
Contact: Kenmei Tkaichi, MD    81+335881111 ext 7065    takaichi@toranomon.gr.jp   
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
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   
Department of Urology, Teikyo University, School of Medicine
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   
Sponsors and Collaborators
Kyorin University
Ministry of Health, Labour and Welfare, Japan
Investigators
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Study Chair: Eiji Higashihara, M.D. Kyorin University, School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00541853    
Other Study ID Numbers: ADPKDCCB
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: October 18, 2007
Last Verified: October 2007
Keywords provided by Kyorin University:
Autosomal Dominant Polycystic Kidney Disease
Hypertension
Angiotensin-2 Receptor Blocker
Calcium Channel Blocker
Kidney Volume
Additional relevant MeSH terms:
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Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Congenital Abnormalities
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Abnormalities, Multiple
Ciliopathies
Genetic Diseases, Inborn
Candesartan
 Candesartan cilexetil
Cilnidipine
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs