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

Phase 2

• Conditions: Kidney, Polycystic, Autosomal Dominant
• Interventions: Drug: Cilnidipine; Drug: Imidapril

• Registration Number: NCT00890279
• Lead Sponsor: Ministry of Health, Labour and Welfare, Japan

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Study Start: 2009-07
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-01
• Last Update Posted: 2009-12-02
• Primary Completion: 2010-06
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cilnidipine	Cilnidipine	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.
Imidapril	Imidapril	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.

Primary Outcome Measures

Name	Time	Method
eGFR	every 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

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

Department of Medicine II, Nippon Medical School; 🇯🇵 Bunkyo-ku, Tokyo, Japan

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

Toranomon Hospital, Kidney center; 🇯🇵 Minato-ku, Tokyo, Japan

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

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

Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences; 🇯🇵 Niigata, Japan

Department of Medicine II, Hokkaido Univserity School of Medicine; 🇯🇵 Sapporo, Hokkaido, Japan

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