UMIN ID: UMIN000002150
Registered date:01/07/2009
Open-label multicenter randomized trial on the effects of sevelamer hydrochloride and calcium carbonate on vascular calcification in patients on maintenance hemodialysis
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Coronary artery calcification in chronic renal failure patients undergoing hemodialysis |
| Date of first enrollment | 2004/04/01 |
| Target sample size | 260 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | One-year treatment with sevelamer hydrochloride alone or combined use of sevelamer hydrochloride and calcium-based products One-year treatment with calcium carbonate alone |
Outcome(s)
| Primary Outcome | Group-to-group comparisons of the changes in coronary artery calcification score and blood parameters including plasma pentosidine concentration occurring during one year of test drug administration from enrollment |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Patients who have received the test drugs within 12 weeks of enrollment 2. Patients who have undergone parathyroidectomy within one year of enrollment 3. Patients who have undergone parathyroid-targeted interventions (intra-parathyroid injection of ethanol, acetic acid, or vitamin D and its derivatives) within 24 weeks of enrollment 4. Patients who have received bisphosphonate products within 12 weeks of enrollment 5. Patients on estrogen replacement therapy 6. Patients receiving elcitonin 7. Patients receiving nicotinamide 8. Patients receiving sodium ferrous citrate (Proprietary name: Ferromia and others) 9. Patients receiving ipriflavone (Proprietary name: Osten and others) 10. Patients receiving vitamin K2 |
Related Information
| Primary Sponsor | Division of Nephrology and Metabolism, Department of Internal Medicine,Tokai University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The Japan Dialysis Outcomes Research Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Shimokasuya 143, Isehara, Kanagawa, Japan Japan |
| Telephone | |
| Affiliation | Tokai University School of Medicine Division of Nephrology and Metabolism, Department of Internal Medicine |
| scientific contact | |
| Name | Takatoshi Kakuta |
| Address | Shimokasuya 143, Isehara, Kanagawa 259-1193, Japan. Japan |
| Telephone | 0463-93-1121 |
| Affiliation | Tokai University School of Medicine Division of Nephrology and Metabolism, Department of Internal Medicine |