Efficacy of Cinacalcet in the Treatment of Secondary Hyperparathyroidism

Phase 2

Recruiting

• Conditions: Secondary hyperparathyroidism.; Secondary hyperparathyroidism of renal origin; N25.81

• Registration Number: IRCT20200218046533N1
• Lead Sponsor: Gorgan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Aged 18 years and more;
Dialysis for at least 3 months;
iPTH levels above 800 pg/dL (severe secondary hyperparathyroidism);
Do not take medications that have drug interactions such as flecainide, thioridazine, tricyclic antidepressants due to the effect of Cinacalcet on the P-450 cytochrome;
No hypersensitivity reaction to the drugs used in the study;
No liver disease;
Calcium levels > 8.4 mg/dL.

Exclusion Criteria

Any evidence of cancer in different parts of the body;
Side effects of the medications used during the study period;
Diseases causing hypercalcemia;
History of parathyroidctomy;
Presence of parathyroid adenoma (to be confirmed by parathyroid scan);
Pregnant mothers or lactating women or females of childbearing age who do not currently use contraception.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decreased parathyroid hormone levels. Timepoint: Before study and 3 and 6 months after treatment. Method of measurement: Blood test.

Secondary Outcome Measures

Name	Time	Method
Decreased serum phosphorus and calcium levels. Timepoint: Before study and 3 and 6 months after treatment. Method of measurement: Blood test.