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Effect of sevelamer-hydrochloride therapy on serum phosphate levels in idiopathic-hypoparathyroidism patients with hyperphosphatemia

Randomized crossover trial for the effect of sevelamer-hydrochloride as adjuvant on serum phosphate in patients with idiopathic-hypoparathyroidism hyperphosphatemia on standard conventional therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078414
Enrollment
60
Registered
2024-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: - Health Condition 2: E200- Idiopathic hypoparathyroidism

Interventions

Intervention1: Sevelamer-hydrochloride along with on-going conventional therapy i.e, alphacalcidol and oral calcium: Patients with Idiopathic Hypoparathyroidism will be randomized into two arms: 1) Se

Sponsors

Indian Council of Medical Research-ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with idiopathic hypoparathyroidism with optimal calcium control i.e, serum total calcium value between 8.0-9.5 mg/dl on conventional therapy and have hyperphosphatemia i.e serum phosphate at least 5.0 mg/dl on last three visits during past one-year of follow-up will be considered eligible for the study.

Exclusion criteria

Exclusion criteria: 1. Patients with idiopathic hypoparathyroidism younger than 18 years or more than 75 years 2. pregnant, lactating, on steroid therapy for any reason, or have serious coexisting medical illness 3. Patients who will be unable to come for repeat follow-up at frequent interval (total 10 visits during study period of 10 months) will be excluded.

Design outcomes

Primary

MeasureTime frame
Reduction of serum-phosphate by 0.5 mg/dL and normalisation of hyperphosphatemia will be an expected outcome.Timepoint: After 4 months of sevelamer hydrochloride therapy

Secondary

MeasureTime frame
Reduction in 24 hour urinary phosphate excretion & Fractional excretion of phosphorus (FEPh) after 4 months of sevelamer hydrochloride therapyTimepoint: After 4 months of sevelamer hydrochloride therapy

Countries

India

Contacts

Public ContactRavinder Goswami

All India Institute of Sciences

gosravinder@hotmail.com09818130879

Outcome results

None listed

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