UMIN ID: UMIN000001478
Registered date:25/10/2009
A combination of cinacalcet with maxacalcitol for regression of moderate to advanced secondary hyperparathyroidism in patients on chronic hemodialysis
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | secondary hyperparathyroidism |
| Date of first enrollment | 2008/04/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | High doses of cinacalcet and maxacalcitol |
Outcome(s)
| Primary Outcome | Indication of parathyroidectomy or other intervention therapy by sustained high intact PTH level (>1000 pg/ml) |
|---|---|
| Secondary Outcome | 1) Difficulty of management of calcium and phosphate by a combination of cinacalcet and maxacalcitol 2) Low iPTH (<30 pg/ml) 3) Adynamic bone 4) Cardiovascular events |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Uncontrolled ischemic heart disease, heart failure, and arrhythmia 2) Stroke within 6 months 3) Peripheral artery didease of Fontaine 3 and 4 4) Severe liver cirrhosis 5) Malignancy within 3 years 6) Uncontrolled phychosis 7) Attendant for other clinical studies within 3 months 8) Pregnant woman or man who wish for baby 9) Unsuitable patients |
Related Information
| Primary Sponsor | Kitano Hospital Division of Nephrology and Dialysis |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tatsuo Tsukamoto |
| Address | 2-4-20 Ohgimachi, Kita-ku, Osaka Japan |
| Telephone | 06-6312-8831 |
| Affiliation | Kitano Hospital, The Tazuke Kofukai Medical Institute Division of Nephrology and Dialysis |
| scientific contact | |
| Name | Tatsuo Tsukamoto |
| Address | 2-4-20 Ohgimachi, Kita-ku, Osaka Japan |
| Telephone | 06-6312-8831 |
| Affiliation | Kitano Hospital, The Tazuke Kofukai Medical Institute Division of Nephrology and Dialysis |