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Efficacy of Cinacalcet in the Treatment of Secondary Hyperparathyroidism

The Evaluation of the Efficacy of Calcitriol Compared to Calcitriol plus Cinacalcet in the Treatment of Severe Secondary Hyperparathyroidism in Hemodialysis Patients Referred to Dialysis Centers in Gorgan

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200218046533N1
Enrollment
70
Registered
2020-05-31
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Secondary hyperparathyroidism. Secondary hyperparathyroidism of renal origin

Interventions

Intervention 1: Intervention group A: Receiving Calcitriol 1 mg orally every other night. Intervention 2: Intervention group B: Receiving Calcitriol 1 mg orally every other night plus Cinacalcet 30 mg

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSedigheh Ebrahimi

Gorgan University of Medical Sciences

infosayyad@goums.ac.ir+98 17 3220 2291

Outcome results

None listed

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