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

NCT00413101 | Completed Phase 4

• 1 other identifier: ML20201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (2)

• Hb level, BP.

  Throughout study

• LVMI ejection fraction, ejection fraction.

  12 months

Secondary Outcomes (1)

• SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

Drug: epoetin beta [NeoRecormon]

Interventions

epoetin beta [NeoRecormon] DRUG

At a dose to achieve and maintain an Hb level of 120-135g/L

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Novi Sad, 21000, Serbia

Location

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Completion: March 1, 2008
• Last Updated: May 14, 2009

Record last verified: 2009-05

Locations

SE (1)