A Study of NeoRecormon in Patients With Chronic Kidney Disease.

Anemia Clinical Trial

Official title:

An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437723
• Other study ID #: ML20200
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2007
• Last updated: May 13, 2009
• Est. completion date: April 2008

Study information

• Verified date: May 2009
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients,18-75 years of age;

• end-stage renal disease, not on dialysis;

• Hb <110g/L.

Exclusion Criteria:

• unstable hypertension;

• acute infections;

• use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;

• myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• epoetin beta [NeoRecormon]
At a dose to achieve and maintain an Hb level of 120-135g/dL.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hb level, decline in renal function, 24h proteinuria, creatinine clearance.		Throughout study	No
Secondary	SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.		Throughout study	No