A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827266
• Other study ID #: ML18730
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2016
• Last updated: July 5, 2016
• Start date: October 2005
• Est. completion date: January 2008

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps Agence française de sécurité sanitaire des produits de santé (SaintDenis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Epoetin beta
Participants will receive epoetin beta as a weekly subcutaneous (SC) injection over an 8-week correction phase with 60 international units per kilograms (IU/kg) as starting dose. Baseline weight will be used to determine the dose and adjustments in the dose will be implemented based on the participant's blood hemoglobin levels. Participants with a response to correction treatment will then enter a 4-week extension phase to receive the SC injection every 2 weeks, and those without response will continue at the same weekly dose for a 4-week continuation phase.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase		Week 8	No
Secondary	Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Extension Phase		Week 12	No
Secondary	Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Continuation Phase		Week 12	No
Secondary	Quality of Life of Participants as Assessed From Short Form 36 (SF-36) Scores		Baseline, Week 8, 12	No
Secondary	Percentage of Participants With Positive Response to Questionnaire for Practicality and Safety of Self-administration of Study Drug		Week 8, 12	No
Secondary	Number of Participants With Local Injection Site Reactions		Up to 12 weeks	Yes
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to 12 weeks	No
Secondary	Number of Participants With Chronic Kidney Disease		Baseline	No
Secondary	Response to Treatment at the end of the Correction Phase Among Participants With Different Time Since Diabetes Diagnosis		Week 8	No
Secondary	Response to Treatment at the end of the Correction Phase Among Participants With Different Hemoglobin Levels at Baseline		Week 8	No
Secondary	Response to Treatment at the end of the Correction Phase Among Participants With Different Hematocrit at Baseline		Week 8	No
Secondary	Number of Participants per Category of History of Medical Disorders and Surgical Procedures		Baseline	No
Secondary	Number of Participants per Type of Diabetes		Week 8, 12	No