CCB Safety Study in Treatment of Hypertension of ADPKD

Phase 4

• Conditions: Kidney, Polycystic, Autosomal Dominant
• Interventions: Drug: Candesartan and Cilnidipine; Drug: Candesartan plus non-CCB agents; Drug: Candesartan

• Registration Number: NCT00541853
• Lead Sponsor: Kyorin University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-10
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Last Update Submitted: 2007-10-17
• Last Update Posted: 2007-10-18
• Study Start: 2007-12
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Candesartan and Cilnidipine	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.
C	Candesartan plus non-CCB agents	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.
A	Candesartan	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.

Primary Outcome Measures

Name	Time	Method
Kidney Volume measured by MRI.	Every year

Secondary Outcome Measures

Name	Time	Method
Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events	any time during study period

Trial Locations

Locations (6)

Toranomon Hospital, Kidney center; 🇯🇵 Tokyo, Japan

Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine; 🇯🇵 Tokyo, Japan

Department of Urology, Teikyo University, School of Medicine; 🇯🇵 Tokyo, Japan

Toranomon Hospital Kajigaya, Kidney center; 🇯🇵 Kanagawa, Japan

Department of Urology, National Hospital Organaization Chiba-East Hospital; 🇯🇵 Chiba, Chiba, Japan

Kyorin University School of Medicine; 🇯🇵 Mitaka, Tokyo, Japan