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

Phase 1

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

• Registration Number: EUCTR2006-003502-26-GB
• Lead Sponsor: Barts and the London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-16
• Study Completion: 2011-09-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Male and female patients greater than 3 months Post Kidney Transplant.
2) Age >18 years and < 80 years
3) Haemoglobin >9g/dl and <11.5g/dl

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> ;<br> 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.<br><br> ;<br> Primary end point(s): 1)Change in Glomerular Filtration Rate as determined by estaimated GFR calculations<br> 2)Change in proteinuria as measured by Albumin:Creatinine Ratio<br> 3)Change in blood pressure and change in requirements for anti-hypertensives<br>