Health Condition 1: N189- Chronic kidney disease, unspecified Health 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??
Conditions
Interventions
Intervention1: PEGEPO (Pegylated Erythropoietin) (Zydus, CHL): Part A and Part B
PEGEPO (Zydus, CHL) -Dose-0.15mcg/kg, 0.3mcg/kg, 0.6mcg/kg and 0.9mcg/kg (Optional dose 1.2mcg/kg)
Route-subcutaneous
Sponsors
Zydus Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Part A 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. 2. Patients receiving regular haemodialysis two to three times per week for at least 8 weeks. 3. Patients having haemoglobin level 6.5-10gm/dl at screening visit. 4. Patients with at least 20% of TSAT and >=200 ng/mL of ferritin at screening. 5. Subject has given informed consent for participation in this trial.
Exclusion criteria
Exclusion criteria: Part A 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A. To monitor the Safety/ -Tolerability Evaluation based on following parameters 1. Number of subjects with adverse events, 2. Physical examinations (Vital signs) 3. Electrocardiogram (ECG), 4. Laboratory tests (including hematology, biochemistry, urinalysis) Part B Change in reticulocyte count, over time for 21 days across various treatment groups.Timepoint: Part B-21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A To evaluate pharmacodynamic and pharmacokinetic properties of PEG-EPO of Cadila Healthcare Ltd in healthy human subjects. Part B- Secondary endpoints will be evaluated across various treatment groups on following parameters:Timepoint: PD-predose and at 24.00, 48.00, 72.00, 144.00, 288.00, 504.00, 672.00, 840.00, and 1008.00 hours following dose of drug administration. PK-predose and at 1.00, 2.00, 4.00, 8.00, 12.00, 24.00, 48.00, 72.00, 144.00, 216.00, 288.00, 360.00, 504.00, 672.00, 840.00 and 1008.00 hours following dose of drug | — |
Countries
India
Contacts
Public ContactDr R H Jani
Cadila Healthcare Limited
Outcome results
None listed