A randomised control trial of the use of Epoetin Beta in the treatment of Post Transplant Anaemia - Epoetin Beta in PTA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003502-26-GB

Enrollment

120

Registered

2006-10-16

Start date

2006-12-14

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Post Transplant Anaemia MedDRA version: 8.1 Level: LLT Classification code 10002071 Term: Anaemia NOS

Interventions

Trade Name: NeoRecormon Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: EPOETIN BETA CAS Number: 122312543

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male and female patients greater than 3 months Post Kidney Transplant. 2) Age >18 years and 9g/dl and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Currently on an Erythropoietin Stimulating Agent 2) Uncontrolled Hypertension 3) Congestive Cardiac Failure 4) History of Seizures 5) History of thrombotic episodes 6) Pregnancy 7) Lactation 8) Presence of systemic disease, infection or inflammatory conditions 9) Hepatic Insufficiency 10)Active Hepatitis 11)Uncontrolled hypothyroidism 12)Chronic Alcoholism 13)Known hypersensitivity to the active substance in the cartridge or benzoic acid. 14)Known sensitivity to Epoetin Beta

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to determine whether the treatment of Post Transplant Anaemia with Epoetin Beta has an effect on the rate of decline of renal function, quantity of proteinuria and blood pressure control. ; Secondary Objective: The secondary objective is to determine whether the treatment of Post Transplant Anaemia with Epoetin Beta has an effect on quality of life and markers of cardiovascular disease;renal tubular damage and endothelial dysfunction. ; Primary end point(s): 1)Change in Glomerular Filtration Rate as determined by estaimated GFR calculations 2)Change in proteinuria as measured by Albumin:Creatinine Ratio 3)Change in blood pressure and change in requirements for anti-hypertensives	—

Measure

Time frame

Main Objective: The primary objective is to determine whether the treatment of Post Transplant Anaemia with Epoetin Beta has an effect on the rate of decline of renal function, quantity of proteinuria and blood pressure control. ; Secondary Objective: The secondary objective is to determine whether the treatment of Post Transplant Anaemia with Epoetin Beta has an effect on quality of life and markers of cardiovascular disease;renal tubular damage and endothelial dysfunction. ; Primary end point(s): 1)Change in Glomerular Filtration Rate as determined by estaimated GFR calculations 2)Change in proteinuria as measured by Albumin:Creatinine Ratio 3)Change in blood pressure and change in requirements for anti-hypertensives

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Countries

United Kingdom

Outcome results

None listed

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