CCB Safety Study in Treatment of Hypertension of ADPKD

Kyorin University

Status and phase: Unknown; Phase 4

Conditions: Kidney, Polycystic, Autosomal Dominant

Treatments: Drug: Candesartan plus non-CCB agents; Drug: Candesartan and Cilnidipine; Drug: Candesartan

Study type: Interventional

Funder types: Other

Identifiers

NCT00541853

ADPKDCCB

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

A

Active Comparator group

Description:

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.

Treatment:

Drug: Candesartan

B

Experimental group

Description:

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.

Treatment:

Drug: Candesartan and Cilnidipine

C

Active Comparator group

Description:

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.

Treatment:

Drug: Candesartan plus non-CCB agents