This is type of Real world, Prospective, Observational Multicenter Study to Monitor the Routine Clinical Use of Pegylated Erythropoetin (PegEPO) in the Treatment of Anemia due to Chronic Kidney Disease.
Phase 4
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2024/04/065664
- Lead Sponsor
- Dr. Sanjay Srinivas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
(1.) Adult male or female patients, diagnosed with CKD stage IV-V (Non-Dialysis) or on Maintenance Haemodialysis (greater or equal to 3 months) and who require treatment with PegEPO will be enrolled.
(2.) Patients on rEPO/ DPO with stable dosing for 3 months.
(3.) Hb- 7 to 10g/dl.
(4.) Patients should be iron replenished and not be suffering from iron deficiency.
(5.) Patients willing to provide informed consent.
(6.) Patients receiving PegEPO as part of routine clinical practice.
Exclusion Criteria
(1.) Any patient who does not fit the inclusion criteria as per physicians opinion or not fit for PegEPO therapy as per PI.
(2.) Patient with a history of hypersensitivity reactions or contraindication to the excipients of Peg EPO.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To monitor the routine clinical use of PegEPO in Indian CKD patients and to assess the real-world efficacy and safety of PegEPO among Indian patients suffering from anemia due to CKD.Timepoint: Time to increase in Hb by 1gm percent from baseline.
- Secondary Outcome Measures
Name Time Method To assess the safety of PegEPO in CKD patients.Timepoint: From baseline to 1 month, 3 month and 6 months.