CCB Safety Study in Treatment of Hypertension of ADPKD
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| ClinicalTrials.gov Identifier: NCT00541853 |
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Recruitment Status : Unknown
Verified October 2007 by Kyorin University.
Recruitment status was: Not yet recruiting
First Posted : October 10, 2007
Last Update Posted : October 18, 2007
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Sponsor:
Kyorin University
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Kyorin University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney, Polycystic, Autosomal Dominant | Drug: Candesartan Drug: Candesartan and Cilnidipine Drug: Candesartan plus non-CCB agents | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients |
| Study Start Date : | December 2007 |
| Estimated Study Completion Date : | November 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 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.
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Drug: Candesartan
Candesartan upto 8mg |
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Experimental: 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.
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Drug: Candesartan and Cilnidipine
Candesartan upto 8mg per day and Cilnidipine upto 20mg per day |
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Active Comparator: 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.
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Drug: Candesartan plus non-CCB agents
Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI |
Primary Outcome Measures :
- Kidney Volume measured by MRI. [ Time Frame: Every year ]
Secondary Outcome Measures :
- Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: any time during study period ]
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| Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541853
Contacts
| Contact: Eiji Higashihara, M.D. | +81-422-47-5511 ext 5813 | ehigashi@kyorin-u.ac.jp |
Locations
| Japan | |
| Kyorin University School of Medicine | Not yet recruiting |
| Mitaka, Tokyo, Japan, 181-8611 | |
| Contact: Eiji Higashihara, M.D. 81+422475511 ext 5813 ehigashi@kyorin-u.ac.jp | |
| Contact: Kikuo Nutahara, M.D. 81-422475511 ext 5815 kinuta@kyorin-u.ac.jp | |
| Department of Urology, National Hospital Organaization Chiba-East Hospital | Not yet recruiting |
| Chiba, Chiba, Japan, 260-8712 | |
| Contact: Koichi Kamura, MD 81+432615171 ext 7607 kamura@cehpnet.com | |
| Toranomon Hospital Kajigaya, Kidney center | Not yet recruiting |
| Kanagawa, Japan, 213-8587 | |
| Contact: Yoshifumi Ubara, MD 81+448775111 ext 6064 ubara@toranomon.gr.jp | |
| Toranomon Hospital, Kidney center | Not yet recruiting |
| Tokyo, Japan, 105-8470 | |
| Contact: Kenmei Tkaichi, MD 81+335881111 ext 7065 takaichi@toranomon.gr.jp | |
| Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine | Not yet recruiting |
| Tokyo, Japan, 105-8471 | |
| Contact: Tatsuo Hosoya, MD 81+334331111 ext 3220 t-hosoya@jikei.ac.jp | |
| Contact: Kazushige Hanaoka, MD 81+334331111 ext 3221 khanaoka@jikei.ac.jp | |
| Department of Urology, Teikyo University, School of Medicine | Not yet recruiting |
| Tokyo, Japan, 173-8605 | |
| Contact: Shigeo Horie, MD 81+339641211 shorie@med.teikyo-u.ac.jp | |
| Contact: Satoru Muto, MD 81+33964-1211 muto@med.teikyo-u.ac.jp | |
Sponsors and Collaborators
Kyorin University
Ministry of Health, Labour and Welfare, Japan
Investigators
| Study Chair: | Eiji Higashihara, M.D. | Kyorin University, School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00541853 History of Changes |
| Other Study ID Numbers: |
ADPKDCCB |
| First Posted: | October 10, 2007 Key Record Dates |
| Last Update Posted: | October 18, 2007 |
| Last Verified: | October 2007 |
Keywords provided by Kyorin University:
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Autosomal Dominant Polycystic Kidney Disease Hypertension Angiotensin-2 Receptor Blocker Calcium Channel Blocker Kidney Volume |
Additional relevant MeSH terms:
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Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Kidney Diseases, Cystic Kidney Diseases Urologic Diseases Abnormalities, Multiple Congenital Abnormalities Ciliopathies Genetic Diseases, Inborn Candesartan |
Candesartan cilexetil Cilnidipine Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Physiological Effects of Drugs |