Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe) Health Condition 3: N185- Chronic kidney disease, stage 5
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 250 adult patients (18 to 65yrs) with CKD (stages 3, 4 and 5; not on dialysis) would be enrolled for the study after informed consent for this study. CKD is defined as deranged renal function for more than 3 months with/without evidence of proteinuria. Staging of CKD would be done as per KDOQI guidelines using eGFR by Modification of diet in renal disease (MDRD) formula.
Exclusion criteria
Exclusion criteria: Patients already on vitD replacement therapy would be excluded. Any other co-morbidities requiring vitD supplementation would be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the response to calcitriol therapy would be evaluated in terms of percentage of patients achieving 25% and 50% lowering in PTH levels following institution of calcitriol therapy.Timepoint: At the end of 3 months and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| FGF23 and Klotho would simultaneously be monitored for their appropriateness for development of early biomarkers for evaluating the efficacy of vitD therapy.Timepoint: At the end of 3 months and 6 months. | — |
Countries
India
Contacts
All India Institute of Medical Sciences, New Delhi