Skip to content

Study to Analyze safety, effectiveness and compliance of erythropoietin therapy using WEPOX® Dispopen, A new delivery device, in the management of CKD Anemia

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/07/043917
Enrollment
1500
Registered
2022-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: WEPOX® Dispopen 20,000 IU: 25-100 IU/kg, three times in a week, Subcutaneous route for 3 months Control Intervention1: NOT APPLICABLE: NOT APPLICABLE Control Intervention2: NA: NA

Sponsors

Wockhardt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients newly prescribed with WEPOX Dispopen 20000 IU for anemia due to chronic kidney disease (CKD) Patient willing to comply with the protocol and written Informed Consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Safety of WEPOX Dispopen 20000 IUTimepoint: Baseline and Day 90±7 (visit 2)

Secondary

MeasureTime frame
Rise in Hemoglobin (Hb) levelsTimepoint: Day 0 and Day 90

Countries

India

Contacts

Public ContactDr Khokan Debnath

Wockhardt Ltd.

skamble@wockhardt.com9167723490

Outcome results

None listed

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