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

Kidney, Polycystic, Autosomal Dominant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00890279
• Other study ID #: ADPKDhypertension
• Status: Recruiting
• Phase: Phase 2
• First received: April 28, 2009
• Last updated: December 1, 2009
• Start date: July 2009
• Est. completion date: November 2012

Study information

• Verified date: December 2009
• Source: Ministry of Health, Labour and Welfare, Japan
• Contact: Shigeo Horie, MD
• Phone: +81339642497
• Email: shorie[@]med.teikyo-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Kidney Diseases
• Kidney, Polycystic, Autosomal Dominant
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• Cilnidipine
Cilnidipine up to 20 mg
• Imidapril
Imidapril up to 10 mg per day

Locations

Country	Name	City	State
Japan	Department of Medicine II, Nippon Medical School	Bunkyo-ku	Tokyo
Japan	Department of Urology, National Hospital Organaization Chiba-East Hospital	Chiba
Japan	Department of Urology, Teikyo University School of Medicine	Itabashi-ku	Tokyo
Japan	Toranomon Hospital Kajigaya, Kidney center	Kawasaki	Kanagawa
Japan	Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine	Minato-ku	Tokyo
Japan	Toranomon Hospital, Kidney center	Minato-ku	Tokyo
Japan	Department of Urology, Kyorin University School of Medicine	Mitaka	Tokyo
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

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eGFR		every 6 months	No
Secondary	Kidney Volume measured by MRI		every 3 months to every 2 years	No
Secondary	Serum creatinine level		every 3 months to every 2 years	No
Secondary	Induction of hemodialysis, cardiovascular events and central nervous vascular events		every 3 months to every 2 years	No