drugset / Trial / NCT01633853
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
Phase 4
Completed
204 enrolled
Dongliang Zhang, MD
Beijing Municipal Science & Technology Commission · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.
Timeline
- Start
- 2012-07
- Primary completion
- 2015-09
- Completion
- 2015-09
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Vitamin D2 vs 1,25(OH)2 Vitamin D3; p = 0.554; t-test, 2 sided; note: t=-0.593 NCT01633853 ↗
registry analysis (superiority or other test); Vitamin D2 vs 1,25(OH)2 Vitamin D3; p = 0.694; t-test, 2 sided; note: t=0.394 NCT01633853 ↗
registry analysis (superiority or other test); Vitamin D2 vs 1,25(OH)2 Vitamin D3; p = 0.463; t-test, 2 sided; note: t=-0.736 NCT01633853 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 1,25(OH)2 Vitamin D3 | Unknown | 0.25 ug | Oral |
| Subject | Ergocalciferol | Small molecule | 1.25 mg | Oral |