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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004775-35-GB

Enrollment

120

Registered

2006-11-22

Start date

2006-11-28

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Anaemia in Diabetic Nephropathy 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 Concentration unit: IU international unit(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male and female patients with Diabetic Nephropathy and Chronic Kidney Disease III and IV 2) Age >18 years and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether treating patients with Anaemia and Diabetic Nephropathy with EPOETIN BETA to different target haemoglobin ranges has an effect on rate of deterioration of renal function, need for dialysis and death.;Secondary Objective: To determine whether treating patients with Anaemia and Diabetic Nephropathy with EPOETIN BETA to different target haemoglobin ranges has an effect on quality of life and markers of cardiovascular disease; renal tubular damage and endothelial dysfunction. ;Primary end point(s): 1) Rate of decline of Renal Function as determined by estimated Glomerular Filtration rate. 2) Composite End Point of: - Doubling of creatinine - Reaching end-stage renal failure - Death	—

Measure

Time frame

Main Objective: To determine whether treating patients with Anaemia and Diabetic Nephropathy with EPOETIN BETA to different target haemoglobin ranges has an effect on rate of deterioration of renal function, need for dialysis and death.;Secondary Objective: To determine whether treating patients with Anaemia and Diabetic Nephropathy with EPOETIN BETA to different target haemoglobin ranges has an effect on quality of life and markers of cardiovascular disease; renal tubular damage and endothelial dysfunction. ;Primary end point(s): 1) Rate of decline of Renal Function as determined by estimated Glomerular Filtration rate. 2) Composite End Point of: - Doubling of creatinine - Reaching end-stage renal failure - Death

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Countries

United Kingdom

Outcome results

None listed

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