Clinical trial NCT00541853: CCB Safety Study in Treatment of Hypertension of ADPKD
Official title: Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney, Polycystic, Autosomal Dominant
Keywords: Autosomal Dominant Polycystic Kidney Disease
Hypertension
Angiotensin-2 Receptor Blocker
Calcium Channel Blocker
Kidney Volume
Lead sponsor: Kyorin University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2007-10-10
Enrollment: 150
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 study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.


Eligibility criteria: Inclusion Criteria:

* ADPKD patients.
* Blood pressure measured at out-patient setting is above 130/85 mmHg.
* Age between 20 and 60 years old.
* Plasma creatinine less than 2.0mg in man and 1.5mg in woman.
* 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: Kidney Volume measured by MRI.
timeFrame: Every year
Secondary outcomes:
measure: Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events
timeFrame: any time during study period
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin University School of Medicine
state: Tokyo
city: Chiba, Chiba
country: Japan
facility: Department of Urology, National Hospital Organaization Chiba-East Hospital
city: Kanagawa
country: Japan
facility: Toranomon Hospital Kajigaya, Kidney center
city: Tokyo
country: Japan
facility: Toranomon Hospital, Kidney center
city: Tokyo
country: Japan
facility: Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
city: Tokyo
country: Japan
facility: Department of Urology, Teikyo University, School of Medicine
Study officials:
affiliation: Kyorin University, School of Medicine
name: Eiji Higashihara, M.D.
role: STUDY_CHAIR
References:
citation: Higashihara E, Nutahara K, Horie S, Muto S, Hosoya T, Hanaoka K, Tuchiya K, Kamura K, Takaichi K, Ubara Y, Itomura M, Hamazaki T. The effect of eicosapentaenoic acid on renal function and volume in patients with ADPKD. Nephrol Dial Transplant. 2008 Sep;23(9):2847-52. doi: 10.1093/ndt/gfn144. Epub 2008 Mar 27.