CCB Safety Study in Treatment of Hypertension of ADPKD

Kyorin University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Kidney, Polycystic, Autosomal Dominant

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (6)

Kyorin University School of Medicine

Mitaka, Tokyo, Japan

Department of Urology, National Hospital Organaization Chiba-East Hospital

Chiba, Chiba, Japan

Toranomon Hospital Kajigaya, Kidney center

Kanagawa, Japan

Toranomon Hospital, Kidney center

Tokyo, Japan

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

Tokyo, Japan

Department of Urology, Teikyo University, School of Medicine

Tokyo, Japan

Outcomes

Primary Outcomes

Kidney Volume measured by MRI.

Time frame: Every year

Secondary Outcomes

Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events

Time frame: any time during study period

CCB Safety Study in Treatment of Hypertension of ADPKD

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts