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CCB Safety Study in Treatment of Hypertension of ADPKD

Primary Purpose

Kidney, Polycystic, Autosomal Dominant

Status

Unknown status

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Candesartan

Candesartan and Cilnidipine

Candesartan plus non-CCB agents

About this trial

This is an interventional treatment trial for Kidney, Polycystic, Autosomal Dominant focused on measuring Autosomal Dominant Polycystic Kidney Disease, Hypertension, Angiotensin-2 Receptor Blocker, Calcium Channel Blocker, Kidney Volume

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kyorin University School of Medicine
Department of Urology, National Hospital Organaization Chiba-East Hospital
Toranomon Hospital Kajigaya, Kidney center
Toranomon Hospital, Kidney center
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
Department of Urology, Teikyo University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Kidney Volume measured by MRI.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00541853

First Posted

October 9, 2007

Last Updated

October 17, 2007

Sponsor

Kyorin University

Collaborators

Ministry of Health, Labour and Welfare, Japan

1. Study Identification

Unique Protocol Identification Number

NCT00541853

Brief Title

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

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

December 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Kyorin University

Collaborators

Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney, Polycystic, Autosomal Dominant

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Candesartan

Intervention Description

Candesartan upto 8mg

Intervention Type

Drug

Intervention Name(s)

Candesartan and Cilnidipine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Candesartan plus non-CCB agents

Intervention Description

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

Primary Outcome Measure Information:

Title

Kidney Volume measured by MRI.

Time Frame

Every year

Secondary Outcome Measure Information:

Title

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

Time Frame

any time during study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eiji Higashihara, M.D.

Phone

+81-422-47-5511

Ext

5813

ehigashi@kyorin-u.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eiji Higashihara, M.D.

Organizational Affiliation

Kyorin University, School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Kyorin University School of Medicine

City

Mitaka

State/Province

Tokyo

ZIP/Postal Code

181-8611

Country

Japan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eiji Higashihara, M.D.

Phone

81+422475511

Ext

5813

ehigashi@kyorin-u.ac.jp

First Name & Middle Initial & Last Name & Degree

Kikuo Nutahara, M.D.

Phone

81-422475511

Ext

5815

kinuta@kyorin-u.ac.jp

Facility Name

Department of Urology, National Hospital Organaization Chiba-East Hospital

City

Chiba, Chiba

ZIP/Postal Code

260-8712

Country

Japan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Koichi Kamura, MD

Phone

81+432615171

Ext

7607

kamura@cehpnet.com

Facility Name

Toranomon Hospital Kajigaya, Kidney center

City

Kanagawa

ZIP/Postal Code

213-8587

Country

Japan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yoshifumi Ubara, MD

Phone

81+448775111

Ext

6064

ubara@toranomon.gr.jp

Facility Name

Toranomon Hospital, Kidney center

City

Tokyo

ZIP/Postal Code

105-8470

Country

Japan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenmei Tkaichi, MD

Phone

81+335881111

Ext

7065

takaichi@toranomon.gr.jp

Facility Name

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

City

Tokyo

ZIP/Postal Code

105-8471

Country

Japan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tatsuo Hosoya, MD

Phone

81+334331111

Ext

3220

t-hosoya@jikei.ac.jp

First Name & Middle Initial & Last Name & Degree

Kazushige Hanaoka, MD

Phone

81+334331111

Ext

3221

khanaoka@jikei.ac.jp

Facility Name

Department of Urology, Teikyo University, School of Medicine

City

Tokyo

ZIP/Postal Code

173-8605

Country

Japan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shigeo Horie, MD

Phone

81+339641211

shorie@med.teikyo-u.ac.jp

First Name & Middle Initial & Last Name & Degree

Satoru Muto, MD

Phone

81+33964-1211

muto@med.teikyo-u.ac.jp

12. IPD Sharing Statement

Citations:

PubMed Identifier

18372389

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.

Results Reference

derived

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CCB Safety Study in Treatment of Hypertension of ADPKD

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