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CCB Safety Study in Treatment of Hypertension of ADPKD
This study is not yet open for participant recruitment.
Verified October 2007 by Kyorin University

First Received on October 9, 2007.   Last Updated on October 17, 2007   History of Changes
Sponsor: Kyorin University
Collaborator: Ministry of Health, Labour and Welfare, Japan
Information provided by: Kyorin University
ClinicalTrials.gov Identifier: NCT00541853
  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 IV

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:

Genetics Home Reference related topics: polycystic kidney disease
MedlinePlus related topics: Blood Pressure Medicines Calcium High Blood Pressure
Drug Information available for: Cilnidipine CV 11974 Candesartan cilexetil
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
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    
Toranomon Hospital, Kidney center Not yet recruiting
Tokyo, Japan, 105-8470
Contact: Kenmei Tkaichi, MD     81+335881111 ext 7065     takaichi@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    
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):
Higashihara E, Nutahara K, Horie S, Muto S, Hosoya T, Hanaoka K, Tuchiya K, Kamura K, Takaichi K, Ubara Y, Itomura M, Hamazaki T. The effect of eicosapentaenoic acid on renal function and volume in patients with ADPKD. Nephrol Dial Transplant. 2008 Sep;23(9):2847-52. Epub 2008 Mar 27.

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

ClinicalTrials.gov processed this record on February 09, 2012



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