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This is a 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.

This is prospective observational study of PegEPO usage in CKD population wherein the drug will be used as part of the routine therapy for management of anemia in CKD population - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065689
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

Sponsors

Apex Kidney Care Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1.) Greater than 18 years (2.) CKD patients stage IV-V (Non Dialysis) and Maintenance Haemodialysis patients (greater or equal to 3 months), Both ESA naïve and switchover patients from other ESAs. (3.) Patients on rEPO/ DPO with stable dosing for 3 months. (4.) Hb- 7 to 10g/dl. (5.) Tsat %: greater than 20%. (6.) Ferritin greater than 100 mcg/l

Exclusion criteria

Exclusion criteria: (1.) Any patient who does not fit the inclusion criteria as per physician’s 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
Rise in Hemoglobin levels during study periodTimepoint: Time to increase in Hb by 1gm% from baseline.—

Secondary

MeasureTime frame
-% of time spent in target Hb range (10-12 g/dl) -Time taken to achieve target range -Changes in TSAT levels (3 monthly) -Changes in Iron requirement -Incidence of Adverse events -QoL improvement assessed by SF-36 QuestionnaireTimepoint: from baseline to 1 month, 3 month and 6 months—

Countries

India

Contacts

Public ContactDr Jatin Kothari

Apex Kidney Care Pvt. Ltd.

Jkothari1970@gmail.com9820121010

Outcome results

None listed

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