Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB) alone.
Maximum dosage of candesartan is 8 mg/day. Dosage of imidapril is in the range of 2.5-10 mg/day. Dosage of cilnidipine is in the range of 5-20mg/day.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilnidipine | Experimental | The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group A, blood pressure is controlled by Candesartan plus Cilnidipine. |
|
| Imidapril | Active Comparator | The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group B, blood pressure is controlled by Candesartan plus Imidapril. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilnidipine | Drug | Cilnidipine up to 20 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| eGFR | every 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Volume measured by MRI | every 3 months to every 2 years | |
| Serum creatinine level | every 3 months to every 2 years | |
| Induction of hemodialysis, cardiovascular events and central nervous vascular events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shigeo Horie, MD | Contact | +81339642497 | shorie@med.teikyo-u.ac.jp | |
| Satoru Muto, MD, PhD | Contact | +81339642497 | muto@med.teikyo-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Shigeo Horie, MD | Teikyo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, National Hospital Organaization Chiba-East Hospital | Not yet recruiting | Chiba | Chiba | 2608712 | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Imidapril | Drug | Imidapril up to 10 mg per day |
|
|
| every 3 months to every 2 years |
| Department of Medicine II, Hokkaido Univserity School of Medicine | Recruiting | Sapporo | Hokkaido | 0608638 | Japan |
|
| Toranomon Hospital Kajigaya, Kidney center | Not yet recruiting | Kawasaki | Kanagawa | 2138587 | Japan |
|
| Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences | Not yet recruiting | Niigata | Niigata | 9518510 | Japan |
|
| Department of Medicine II, Nippon Medical School | Not yet recruiting | Bunkyo-ku | Tokyo | 1138602 | Japan |
|
| Department of Urology, Teikyo University School of Medicine | Recruiting | Itabashi-ku | Tokyo | 1738605 | Japan |
|
| Toranomon Hospital, Kidney center | Not yet recruiting | Minato-ku | Tokyo | 1058470 | Japan |
|
| Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine | Active, not recruiting | Minato-ku | Tokyo | 1058471 | Japan |
| Department of Urology, Kyorin University School of Medicine | Not yet recruiting | Mitaka | Tokyo | 1818611 | Japan |
|
| 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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C065927 | cilnidipine |
| C065166 | imidapril |
Not provided
Not provided
Not provided