Clinical trial NCT00890279: Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)
Official title: Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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
Lead sponsor: Ministry of Health, Labour and Welfare, Japan
Sponsor class: OTHER_GOV
First posted: 2009-04-29
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: eGFR
timeFrame: every 6 months
Secondary outcomes:
measure: Kidney Volume measured by MRI
timeFrame: every 3 months to every 2 years
measure: Serum creatinine level
timeFrame: every 3 months to every 2 years
measure: Induction of hemodialysis, cardiovascular events and central nervous vascular events
timeFrame: every 3 months to every 2 years
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Department of Medicine II, Hokkaido Univserity School of Medicine
state: Hokkaido
city: Kawasaki
country: Japan
facility: Toranomon Hospital Kajigaya, Kidney center
state: Kanagawa
city: Bunkyo-ku
country: Japan
facility: Department of Medicine II, Nippon Medical School
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Department of Urology, Teikyo University School of Medicine
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital, Kidney center
state: Tokyo
city: Minato-ku
country: Japan
facility: Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
state: Tokyo
city: Mitaka
country: Japan
facility: Department of Urology, Kyorin University School of Medicine
state: Tokyo
city: Chiba
country: Japan
facility: Department of Urology, National Hospital Organaization Chiba-East Hospital
city: Niigata
country: Japan
facility: Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences
Study officials:
affiliation: Teikyo University
name: Shigeo Horie, MD
role: STUDY_CHAIR
References: