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

Sponsor

Ministry of Health, Labour and Welfare, Japan (Other)

Overall Status

Unknown status

CT.gov ID

NCT00890279

Collaborator

(none)

160

Enrollment

Locations

Arms

Duration (Months)

17.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney, Polycystic, Autosomal Dominant	Drug: Cilnidipine Drug: Imidapril	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Cilnidipine Cilnidipine up to 20 mg Other Names: ATELEC
Active Comparator: 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.	Drug: Imidapril Imidapril up to 10 mg per day Other Names: TANATRIL

Arm

Intervention/Treatment

Experimental: 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.

Drug: Cilnidipine

Cilnidipine up to 20 mg

Other Names:

ATELEC

Active Comparator: 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.

Drug: Imidapril

Imidapril up to 10 mg per day

Other Names:

TANATRIL

Outcome Measures

Primary Outcome Measures

eGFR [every 6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medicine II, Hokkaido Univserity School of Medicine	Sapporo	Hokkaido	Japan	0608638
2	Toranomon Hospital Kajigaya, Kidney center	Kawasaki	Kanagawa	Japan	2138587
3	Department of Medicine II, Nippon Medical School	Bunkyo-ku	Tokyo	Japan	1138602
4	Department of Urology, Teikyo University School of Medicine	Itabashi-ku	Tokyo	Japan	1738605
5	Toranomon Hospital, Kidney center	Minato-ku	Tokyo	Japan	1058470
6	Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine	Minato-ku	Tokyo	Japan	1058471
7	Department of Urology, Kyorin University School of Medicine	Mitaka	Tokyo	Japan	1818611
8	Department of Urology, National Hospital Organaization Chiba-East Hospital	Chiba		Japan	2608712
9	Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences	Niigata		Japan	9518510