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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.

An open, randomised, prospective study to evaluate the efficacy of pulse oral versus daily Calcitriol therapy for controlling secondary hyperparathyroidism in pre-dialysis CKD patients - A pilot study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/12/002263
Enrollment
50
Registered
2011-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Secondary hyperparathyroidism in pre-dialysis CKD

Interventions

Intervention1: Oral calcitriol - pulse therapy: 1ug / 0.75 ug as twice weekly schedule x 6 months Intervention2: Oral calcitriol: 0.25ug 1 OD x 6 months

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

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 8.S.Phosphate 9.Informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Percentage reduction in iPTH levels at the end of 6 monthsTimepoint: 0,1 and 6 months—

Secondary

MeasureTime frame
Hypercalcemia HyperphosphatemiaTimepoint: 0,1,2,3,6—

Countries

India

Contacts

Public ContactDr Yasir Rizvi
skagarwal58@yahoo.co.in01126594911

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026