to evaluate the safety and efficacy of PEGEPO (Pegylated Erythropoietin) in healthy volunteers and patients with chronic renal failure on haemodialysis.â??

Phase 1

Completed

• 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??

• Registration Number: CTRI/2013/01/003278
• Lead Sponsor: Zydus Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified