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| Name | Class |
|---|---|
| Ministry of Health, Labour and Welfare, Japan | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 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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| B | Experimental | 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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| C | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan | Drug | Candesartan upto 8mg |
| |
| Candesartan and Cilnidipine |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Volume measured by MRI. | Every year |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events | any time during study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eiji Higashihara, M.D. | Contact | +81-422-47-5511 | 5813 | ehigashi@kyorin-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Eiji Higashihara, M.D. | Kyorin University, School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyorin University School of Medicine | Mitaka | Tokyo | 181-8611 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356039 | Derived | 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. | |
| 18372389 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 5, 2012 | |
| Reset | May 3, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 5, 2012 | May 3, 2012 |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C081643 | candesartan |
| C065927 | cilnidipine |
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| Drug |
Candesartan upto 8mg per day and Cilnidipine upto 20mg per day |
|
| Candesartan plus non-CCB agents | Drug | Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI |
|
| Department of Urology, National Hospital Organaization Chiba-East Hospital | Chiba, Chiba | 260-8712 | Japan |
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| Toranomon Hospital Kajigaya, Kidney center | Kanagawa | 213-8587 | Japan |
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| Toranomon Hospital, Kidney center | Tokyo | 105-8470 | Japan |
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| Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine | Tokyo | 105-8471 | Japan |
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| Department of Urology, Teikyo University, School of Medicine | Tokyo | 173-8605 | Japan |
|
| 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |