CCB Safety Study in Treatment of Hypertension of ADPKD
Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients
1 other identifier
interventional
150
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2007
Longer than P75 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2007
CompletedFirst Posted
Study publicly available on registry
October 10, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedOctober 18, 2007
October 1, 2007
October 9, 2007
October 17, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Kidney Volume measured by MRI.
Every year
Secondary Outcomes (1)
Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events
any time during study period
Study Arms (3)
A
ACTIVE COMPARATORADPKD 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.
B
EXPERIMENTALThe 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.
C
ACTIVE COMPARATORThe 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.
Interventions
Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyorin Universitylead
- Ministry of Health, Labour and Welfare, Japancollaborator
Study Sites (6)
Kyorin University School of Medicine
Mitaka, Tokyo, 181-8611, Japan
Department of Urology, National Hospital Organaization Chiba-East Hospital
Chiba, Chiba, 260-8712, Japan
Toranomon Hospital Kajigaya, Kidney center
Kanagawa, 213-8587, Japan
Toranomon Hospital, Kidney center
Tokyo, 105-8470, Japan
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
Tokyo, 105-8471, Japan
Department of Urology, Teikyo University, School of Medicine
Tokyo, 173-8605, Japan
Related Publications (2)
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.
PMID: 39356039DERIVEDHigashihara 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.
PMID: 18372389DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eiji Higashihara, M.D.
Kyorin University, School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 9, 2007
First Posted
October 10, 2007
Study Start
December 1, 2007
Study Completion
November 1, 2012
Last Updated
October 18, 2007
Record last verified: 2007-10