CCB Safety Study in Treatment of Hypertension of ADPKD
Information source: Kyorin University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney, Polycystic, Autosomal Dominant
Intervention: Candesartan (Drug); Candesartan and Cilnidipine (Drug); Candesartan plus non-CCB agents (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Kyorin University Official(s) and/or principal investigator(s):
Eiji Higashihara, M.D., Study Chair, Affiliation: Kyorin University, School of Medicine
Overall contact:
Eiji Higashihara, M.D., Phone: +81-422-47-5511, Ext: 5813, Email: ehigashi@kyorin-u.ac.jp
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.
Clinical Details
Official title: Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Kidney Volume measured by MRI.
Secondary outcome: Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events
Eligibility
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Eiji Higashihara, M.D., Phone: +81-422-47-5511, Ext: 5813, Email: ehigashi@kyorin-u.ac.jp
Department of Urology, Teikyo University, School of Medicine, Tokyo 173-8605, Japan
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo 105-8471, Japan
Toranomon Hospital, Kidney center, Tokyo 105-8470, Japan
Toranomon Hospital Kajigaya, Kidney center, Kanagawa 213-8587, Japan
Department of Urology, National Hospital Organaization Chiba-East Hospital, Chiba, Chiba 260-8712, Japan
Kyorin University School of Medicine, Mitaka, Tokyo 181-8611, Japan
Additional Information
Starting date: December 2007
Ending date: November 2012
Last updated: October 17, 2007
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