Official Title: “Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Candesartan
  • Candesartan upto 8mg
• Drug: Candesartan and Cilnidipine
  • Candesartan upto 8mg per day and Cilnidipine upto 20mg per day
• Drug: Candesartan plus non-CCB agents
  • Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.
• 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.

Primary Measures

• Kidney Volume measured by MRI.
  • Time Frame: Every year
    

Secondary Measures

• Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events
  • Time Frame: any time during study period
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kyorin University

Overall Clinical Trial Officials and Contacts

Eiji Higashihara, M.D. Study Chair Kyorin University, School of Medicine  

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

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00541853

Study ID Number: ADPKDCCB

ClinicalTrials.gov Identifier: NCT00541853

Health Authority: Japan: Institutional Review Board