CCB Safety Study in Treatment of Hypertension of ADPKD

NCT ID: NCT00541853

Last Updated: 2007-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-11-30

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.

Conditions

Kidney, Polycystic, Autosomal Dominant

Keywords

Autosomal Dominant Polycystic Kidney Disease; Hypertension; Angiotensin-2 Receptor Blocker; Calcium Channel Blocker; Kidney Volume

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

ADPKD patients with blood pressure above 130/85 are enrolled. The patients whose blood pressure is controlled under 130/85 by Candesartan alone are classified into group A.

Group Type: ACTIVE_COMPARATOR

Candesartan

Intervention Type: DRUG

Candesartan upto 8mg

B

The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group B, blood pressure is controlled by Candesartan plus Cilnidipine. If blood pressure is not lowered by Candesartan plus Cilnidipine alone, another antihypertensive agents except CCB and ACEI are allowable.

Group Type: EXPERIMENTAL

Candesartan and Cilnidipine

Intervention Type: DRUG

Candesartan upto 8mg per day and Cilnidipine upto 20mg per day

C

The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group C, blood pressure is controlled by Candesartan plus non-CCB agents such as beta- or alpha- adrenergic blockers or another ARB. Any CCB and ACEI are not allowable.

Group Type: ACTIVE_COMPARATOR

Candesartan plus non-CCB agents

Intervention Type: DRUG

Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI

Interventions

Candesartan

Candesartan upto 8mg

Intervention Type: DRUG

Candesartan and Cilnidipine

Candesartan upto 8mg per day and Cilnidipine upto 20mg per day

Intervention Type: DRUG

Candesartan plus non-CCB agents

Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: collaborator

Kyorin University

OTHER

Sponsor Role: lead

Principal Investigators

Eiji Higashihara, M.D.

Role: STUDY_CHAIR

Kyorin University, School of Medicine

Locations

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

Countries

Japan

Central Contacts

Eiji Higashihara, M.D.

Role: CONTACT

Phone: +81-422-47-5511

Email: ehigashi@kyorin-u.ac.jp

Facility Contacts

Eiji Higashihara, M.D.

Role: primary

Kikuo Nutahara, M.D.

Role: backup

Koichi Kamura, MD

Role: primary

Yoshifumi Ubara, MD

Role: primary

Kenmei Tkaichi, MD

Role: primary

Tatsuo Hosoya, MD

Role: primary

Kazushige Hanaoka, MD

Role: backup

Shigeo Horie, MD

Role: primary

Satoru Muto, MD

Role: backup

References

St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

Reference Type: DERIVED

PMID: 39356039 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18372389 (View on PubMed)

Other Identifiers

ADPKDCCB

Identifier Type: -

Identifier Source: org_study_id