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

NCT00890279 | Unknown Phase 2

• 1 other identifier: ADPKDhypertension
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 9

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.

Conditions

Kidney, Polycystic, Autosomal Dominant

Keywords

Autosomal Dominant Polycystic Kidney Disease; Hypertension; Angiotensin-II Receptor Blocker; Calcium Channel Blocker; Angiotensin converting enzyme inhibitor; Kidney Volume; eGFR

Outcome Measures

Primary Outcomes (1)

• eGFR

  every 6 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Cilnidipine

EXPERIMENTAL

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

Imidapril

ACTIVE COMPARATOR

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

Interventions

Cilnidipine DRUG

Cilnidipine up to 20 mg

Also known as: ATELEC

Cilnidipine

Imidapril DRUG

Imidapril up to 10 mg per day

Also known as: TANATRIL

Imidapril

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Labour and Welfare, Japan: lead

Study Sites (9)

Department of Urology, National Hospital Organaization Chiba-East Hospital

Chiba, Chiba, 2608712, Japan

NOT YET RECRUITING

Department of Medicine II, Hokkaido Univserity School of Medicine

Sapporo, Hokkaido, 0608638, Japan

RECRUITING

Toranomon Hospital Kajigaya, Kidney center

Kawasaki, Kanagawa, 2138587, Japan

NOT YET RECRUITING

Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences

Niigata, Niigata, 9518510, Japan

NOT YET RECRUITING

Department of Medicine II, Nippon Medical School

Bunkyo-ku, Tokyo, 1138602, Japan

NOT YET RECRUITING

Department of Urology, Teikyo University School of Medicine

Itabashi-ku, Tokyo, 1738605, Japan

RECRUITING

Toranomon Hospital, Kidney center

Minato-ku, Tokyo, 1058470, Japan

NOT YET RECRUITING

Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine

Minato-ku, Tokyo, 1058471, Japan

ACTIVE NOT RECRUITING

Department of Urology, Kyorin University School of Medicine

Mitaka, Tokyo, 1818611, Japan

NOT YET RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Hypertension

Interventions

cilnidipine; imidapril

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shigeo Horie, MD

  Teikyo University

  STUDY CHAIR

Central Study Contacts

Shigeo Horie, MD

CONTACT

+81339642497; shorie@med.teikyo-u.ac.jp

Satoru Muto, MD, PhD

CONTACT

+81339642497; muto@med.teikyo-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 29, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2012
• Last Updated: December 2, 2009

Record last verified: 2009-12

Locations

JP (9)