The Effect of Treating Patients with Anaemia in Diabetic Nephropathy to different target haemoglobin levels with Epoetin Beta - Epoetin Beta in AD

Phase 1

• Conditions: Anaemia in Diabetic Nephropathy; MedDRA version: 8.1Level: LLTClassification code 10002071Term: Anaemia NOS

• Registration Number: EUCTR2006-004775-35-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: 2006-11-22
• Study Completion: 2011-03-15
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1) Male and female patients with Diabetic Nephropathy and Chronic Kidney Disease III and IV
2) Age >18 years and < 80 years
3) Haemoglobin <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) Current treatment with an ESA
2) Uncontrolled Hypertension
3) Congestive Cardiac Failure
4) History of Seizures
5) History of thrombotic episodes
6) Pregnancy
6) 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