CTRI/2013/01/003278
Completed
Phase 1
â??A multicentre, prospective, study to evaluate the safety and efficacy of PEGEPO (Pegylated Erythropoietin) in healthy volunteers and patients with chronic renal failure on haemodialysis.â??
Zydus Research Centre0 sites150 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecifiedHealth Condition 2: null- to evaluate the safety and efficacy of PEGEPO (Pegylated Erythropoietin) in healthy volunteers and patients with chronic renal failure on haemodialysis.â??
- Sponsor
- Zydus Research Centre
- Enrollment
- 150
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male subjects aged between 18 and 60 years (including both).
- •2\. Subjectsâ?? weight within ï?±15% of the ideal height\-weight chart of Life Insurance Corporation of India for non\-medical cases.
- •3\. Ability to communicate effectively with study personnel.
- •4\. Willingness to adhere to the protocol requirements.
- •5\. Able to give consent for participation in the trial.
- •6\. Normal health as determined by personal medical history, clinical examination, and laboratory examinations data during screening(within the clinically acceptable range )
- •7\. Hemoglobin between 11\-13gm/dl
- •8\. Subjects with at least 20% of TSAT and \>\=50 mcg/L of ferritin at screening
- •Part B and Part C
- •1\. Male or female patients diagnosed with chronic renal failure, aged 18 to 65 years.
Exclusion Criteria
- •1\. History of hypersensitivity to Erythropoietin or any other related drug.
- •2\. Active liver disease and/or liver transaminases greater than 1\.5 X upper limit of normal.
- •3\. History of depression necessitating hospitalization, two or more recurrent episodes of depression or suicide attempt.
- •4\. History of epilepsy.
- •5\. History of severe Anaemia.
- •6\. History or presence of blood dyscrasias (e.g., thrombocytopenia, neutropenia).
- •7\. History or presence of thyroid disorders.
- •8\. History or presence of pulmonary disorders (e.g., dyspnoea, pneumonia)
- •9\. History or presence of autoimmune disorders (e.g., thyroiditis, rheumatoid arthritis).
- •10\. History or presence of arrhythmia or any other cardiovascular disease.
Outcomes
Primary Outcomes
Not specified
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