A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.

Anemia Clinical Trial

Official title:

An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413101
• Other study ID #: ML20201
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2006
• Last updated: May 13, 2009
• Est. completion date: March 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 single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 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;

• on renal dialysis >= 3 months;

• receiving NeoRecormon treatment >= 3 months;

• Hb stable and <105g/L, and LVMI >160g/m2.

Exclusion Criteria:

• unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;

• use of any ESA other than NeoRecormon;

• acute infection;

• use of iv NeoRecormon.

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Kidney Failure, Chronic

Intervention

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

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, BP.		Throughout study	No
Primary	LVMI ejection fraction, ejection fraction.		12 months	No
Secondary	SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.		Throughout study	No