NADIR: Multicentre, Open-Label Trial Evaluating a Simple NeoRecormon Regimen in Anemic Patients With Diabetes and Chronic Kidney Disease (Stage 2 to 5) Who Are Not on Dialysis

Hoffmann-La Roche0 sites122 target enrollmentOctober 2005

ConditionsAnemia

InterventionsEpoetin beta

DrugsEpoetin beta

Overview

Phase: Phase 3
Intervention: Epoetin beta
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Enrollment: 122
Primary Endpoint: Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and quality of life in participants with diabetes and chronic renal failure and who are not receiving dialysis.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

January 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 1 or 2 diabetes
•Chronic renal failure (stage 2 to stage 5) defined by Glomerular Filtration Rate (GFR) less than (\<) 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2)
•Anemia related to chronic kidney disease and requiring treatment with erythropoiesis-stimulating agent (ESA) (2 values of hemoglobin less than or equal to 11 gram per deciliter \[g/dL\] during the 3 months prior to inclusion), and hemoglobin greater than 8 g/dL

Exclusion Criteria

•Anemia due to a non-renal cause
•Poorly controlled hypertension
•Treatment with an erythropoiesis stimulating agent (ESA) within 3 months prior to the study
•Planned dialysis in next 3 months or organ transplant
•History of cancer except for basal cell cancer and cervical cancer in situ

Arms & Interventions

Epoetin beta

Participants will receive epoetin beta over an 8-week correction phase and a 4-week extension or continuation phase, for a total exposure of up to 12 weeks.

Intervention: Epoetin beta

Outcomes

Primary Outcomes

Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase

Time Frame: Week 8

Secondary Outcomes

Percentage of Participants With Positive Response to Questionnaire for Practicality and Safety of Self-administration of Study Drug(Week 8, 12)
Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Extension Phase(Week 12)
Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Continuation Phase(Week 12)
Number of Participants With Local Injection Site Reactions(Up to 12 weeks)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 12 weeks)
Number of Participants With Chronic Kidney Disease(Baseline)
Quality of Life of Participants as Assessed From Short Form 36 (SF-36) Scores(Baseline, Week 8, 12)
Response to Treatment at the end of the Correction Phase Among Participants With Different Time Since Diabetes Diagnosis(Week 8)
Response to Treatment at the end of the Correction Phase Among Participants With Different Hemoglobin Levels at Baseline(Week 8)
Response to Treatment at the end of the Correction Phase Among Participants With Different Hematocrit at Baseline(Week 8)
Number of Participants per Category of History of Medical Disorders and Surgical Procedures(Baseline)
Number of Participants per Type of Diabetes(Week 8, 12)