Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)

Study Overview
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Brief Summary
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This phase II study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB) alone.

Detailed Description
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Maximum dosage of candesartan is 8 mg/day. Dosage of imidapril is in the range of 2.5-10 mg/day. Dosage of cilnidipine is in the range of 5-20mg/day.

Official Title
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Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB

Conditions
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Kidney, Polycystic, Autosomal Dominant

Intervention / Treatment
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* Drug: Cilnidipine
* Drug: Imidapril


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 120/80 mmHg Age between 20 and 60 years old eGFR more than 30 ml/min/1.73m2 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 |
| --- | --- |
| Experimental: Cilnidipine<br>The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group A, blood pressure is controlled by Candesartan plus Cilnidipine. | Drug: Cilnidipine<br>* Cilnidipine up to 20 mg<br>* Other names: ATELEC;|
| Active Comparator: Imidapril<br>The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group B, blood pressure is controlled by Candesartan plus Imidapril. | Drug: Imidapril<br>* Imidapril up to 10 mg per day<br>* Other names: TANATRIL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR |  | every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney Volume measured by MRI |  | every 3 months to every 2 years | 
| Serum creatinine level |  | every 3 months to every 2 years | 
| Induction of hemodialysis, cardiovascular events and central nervous vascular events |  | every 3 months to every 2 years | 

 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-II Receptor Blocker, Calcium Channel Blocker, Angiotensin converting enzyme inhibitor, Kidney Volume, eGFR