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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.

A 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. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065664
Enrollment
100
Registered
2024-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Not applicable: Not applicable Control Intervention1: Not applicable: Not applicable

Sponsors

Dr. Sanjay Srinivas
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To assess the safety of PegEPO in CKD patients.Timepoint: From baseline to 1 month, 3 month and 6 months.

Countries

India

Contacts

Public ContactDr Sanjay Srinivas

Dr. Sanjays Center For Kidney and Diabetes

drsanjaysri872@gmail.com9901996755

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026