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Safety, effectiveness and compliance study of Wepox dispopen 20000 IU in the management of Anemia due to Chronic kidney disease.

Prospective Analysis of safety, effectiveness and compliance of EPO (erythropoietin) therapy by using WEPOX® Dispopen 20,000 IU in the management of CKD Anemia - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058943
Enrollment
1800
Registered
2023-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: D631- Anemia in chronic kidney disease

Interventions

Intervention1: WEPOX Dispopen 20,000 IU of recombinant erythropoietin IP injection.: Dose 50-100 IU/Kg, 3x/week Route of administration is subcutaneous. Duration 90 days. Control Intervention1: Nil: N

Sponsors

Wockhardt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patient (age 18-75 years) of any gender. 2. Patients newly prescribed with WEPOX Dispopen 20000 IU for anemia due to chronic kidney disease (CKD). 3. Patient willing to comply with the protocol and written Informed Consent.

Exclusion criteria

Exclusion criteria: 1.Patients who do not meet requirement as per prescribing information of WEPOX Dispopen 20000 IU 2.Pregnant and lactating females

Design outcomes

Primary

MeasureTime frame
1. Incidence of adverse event 2.Incidence of serious adverse event 3. Pain at injection site 4.Discomfort at injection site Timepoint: At day 90±7

Secondary

MeasureTime frame
Confidence in administrationTimepoint: At day 90±7;Ease of administering accurate doseTimepoint: At day 90±7;Ease of storageTimepoint: At day 90±7;Ease of use of penTimepoint: At day 90±7;Medication ComplianceTimepoint: At day 90±7;rise in Hemoglobin (Hb) levelsTimepoint: Baseline and at day 90±7

Countries

India

Contacts

Public ContactDr Kokhan Debnath

Wockhardt Ltd

purushothamVS@wockhardt.com919739270420

Outcome results

None listed

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