A clinical trial to study the efficacy of daily versus twice weekly therapy with oral calcitriol for controlling secondary hyperparathyroidsim in pre-dialysis CKD patients.
Not Applicable
- Conditions
- Health Condition 1: null- Secondary hyperparathyroidism in pre-dialysis CKD
- Registration Number
- CTRI/2011/12/002263
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1.Adults ( >18 years)
2.Both male and females
3.CKD Stage 3 (eGFR 30-59 ml/min/1.73 m2)
4.CKD Stage 4 (eGFR 15-29 ml/min/1.73 m2)
5.iPTH > 110 pg/ml (CKD-3)
6.iPTH > 150 pg/ml (CKD-4)
7.S. Calcium < 10.5 mg/dl
8.S.Phosphate < 4.6 mg/dl
9.Informed consent
Exclusion Criteria
1.Pregnant or lactating females
2.Female patients unwilling for birth control
3.Evidence of cancer or active infections
4.Impaired LFT (SGPT >2times Upper limit normal)
5.Receiving any form of Vitamin D or cinacalcet within 4 weeks prior to screening
6.Receiving bisphosphonate/calcitonin within previous 12 months
7.History of prior transplant
8.Any active alcohol/drug dependence or abuse
9.On steroids > 30 days within previous 6 month
10.Previous parathyroidectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage reduction in iPTH levels at the end of 6 monthsTimepoint: 0,1 and 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Hypercalcemia <br/ ><br>HyperphosphatemiaTimepoint: 0,1,2,3,6