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A Study to Observe Pure Red Cell Aplasia (PRCA) Occurrence in Patients with Chronic Kidney Disease Who Used Hema-Plus (Recombinant Human Erythropoietin Alfa) at Ramathibodi Hospital

A Study to Observe Pure Red Cell Aplasia (PRCA) Occurrence in Patients with Chronic Kidney Disease Who Used Hema-Plus (Recombinant Human Erythropoietin Alfa) at Ramathibodi Hospital

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
TCTR
Registry ID
TCTR20170807003
Enrollment
40
Registered
2017-08-07
Start date
2017-07-08
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

&#45

Interventions

Patients who presented with chronic kidney disease (CKD) and had history of receiving Hema&#45
Plus for at least 12 months during the study period.
Other
Treatment group

Sponsors

Apexcela Co., Ltd.
Lead Sponsor
Siam Bioscience Co.&#44
Collaborator
Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Each patient included in the review must meet all of the following criteria to be in this study: 1. Presented with chronic kidney disease (CKD). 2. History of receiving Hema-Plus for at least 12 months during the study period.

Exclusion criteria

Exclusion criteria: Patients who met inclusion criteria but their medical records are not available for access.

Design outcomes

Primary

MeasureTime frame
Event Pure Red Cell Aplasia (PRCA) After treated by study drug Number of PRCA case from medical record review,Hema-Plus treatment dose and exposure time After treated by study drug dose and duration of Hema-Plus treatment which receive from medical record review

Secondary

MeasureTime frame
NA NA NA

Countries

Thailand

Contacts

Public ContactNarumon Werayingyong

Siam Bioscience Co., Ltd.

narumonw@siambioscience.com02 613 9939

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026