UMIN ID: UMIN000001656
Registered date:25/01/2009
Evaluation of efficacy and safety of active vitamin D treatment for secondary hyperparathyroidism in patients on maintenance hemodialysis; competitive study
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | secondary hyperparathyroidism(SHPT) |
| Date of first enrollment | 2008/06/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | affacalcidol maxacalcitol |
Outcome(s)
| Primary Outcome | The percentage achievement of recommendation value (60-180pg/mL) of intact parathyroid hormone(PTH). |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Malignancy,malnutrition, active inflammatory or infectious disease 2)Severe heart failure and liver dysfunction 3)Pregnancy, during breast-feeding 4)Patients with allergy to affacalcidol and maxacalcitol 5)Primary hyperparathyroidism patients 6)Aluminum and Fe associated bone disease patients 7)Post parathyroidectomy patients, patients received percutaneous ethanol or vitamin D injection 8) Judged inappropriate for this study by the physicians 9)Parients who were recruited another clinical trial within 3 months |
Related Information
| Primary Sponsor | Division of Nephrology Department of Medicine Showa University School of Medicin |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Division of Nephrology Department of Medicine Showa University School of Medicin |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| hondah@med.showa-u.ac.jp | |
| Affiliation | Showa University Showa University School of Medicine Division of Nephrology Department of Medicine |
| scientific contact | |
| Name | Hirokazu Honda |
| Address | 1-5-8, Hatanodai, Shinagawaku, Tokyo, Japan Japan |
| Telephone | |
| Affiliation | Showa University School of Medicine Division of Nephrology , Department of Medicine |