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Cyproheptadine for appetite and nutritional indicators in hemodialysis patients
IRCT20220329054368N2Phase 3
Key facts
- Status
- Completed
- Start
- May 2023
- Countries
- 1
- Sponsor
- Yasouj University of Medical Sciences
- Modality
- Small Molecules
- Drugs
- cyproheptadine
- Conditions
- chronic kidney disease (CKD)
01
Overview
Phase 3, randomised trial in chronic kidney disease (CKD) comparing Cyproheptadine + routine treatment with Placebo + routine treatment (2 arms). Primary endpoints: Improvement in physiological conditions and quality of life, Appetite and 2 more. Started May 2023; status: completed.
02
Design
2 arms- Study design
- Randomized
Cyproheptadine + routine treatment
Participants receive cyproheptadine 4 mg daily plus routine hemodialysis care.
Placebo + routine treatment
Participants receive placebo plus routine hemodialysis care.
03
Who it enrols
Adults aged 18 to 80 years with chronic kidney disease on maintenance hemodialysis were eligible if at least 3 months had passed since dialysis initiation, they underwent dialysis twice weekly with good efficacy, and they consented to participate. Patients were excluded for conditions or medications that could cause or increase appetite, including active infection, uncompensated heart failure, malignancy, liver cirrhosis, COVID-19, tricyclic antidepressants, corticosteroids, organ transplant history, migration, death, withdrawal of consent, or development of new infectious or chronic disease…
04
Endpoints
Primary
Improvement in physiological conditions and quality of life
Appetite
Laboratory indicators
Anthropometric indicators
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