CCB Safety Study in Treatment of Hypertension of ADPKD

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney, Polycystic, Autosomal Dominant

Intervention / Treatment
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* Drug: Candesartan
* Drug: Candesartan and Cilnidipine
* Drug: Candesartan plus non-CCB agents


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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<br>* Candesartan upto 8mg<br>|
| Experimental: B<br>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<br>* Candesartan upto 8mg per day and Cilnidipine upto 20mg per day<br>|
| Active Comparator: C<br>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<br>* Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney Volume measured by MRI. |  | Every year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events |  | any time during study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autosomal Dominant Polycystic Kidney Disease, Hypertension, Angiotensin-2 Receptor Blocker, Calcium Channel Blocker, Kidney Volume