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

Hoffmann-La Roche122 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Anemia

Interventions

Epoetin betaDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (78)

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 Hemoglobin >11 g/dL After 4-Week Extension Phase

Time frame: Week 12

Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Continuation Phase

Time frame: Week 12

Quality of Life of Participants as Assessed From Short Form 36 (SF-36) Scores

Time frame: Baseline, Week 8, 12

Percentage of Participants With Positive Response to Questionnaire for Practicality and Safety of Self-administration of Study Drug

Time frame: Week 8, 12

Number of Participants With Local Injection Site Reactions

Time frame: Up to 12 weeks

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to 12 weeks

Number of Participants With Chronic Kidney Disease

Time frame: Baseline

Response to Treatment at the end of the Correction Phase Among Participants With Different Time Since Diabetes Diagnosis

Time frame: Week 8

Response to Treatment at the end of the Correction Phase Among Participants With Different Hemoglobin Levels at Baseline

Time frame: Week 8

Data from ClinicalTrials.gov

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Unnamed facility

Aix-en-Provence, France

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Angers, France

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Annonay, France

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Arras, France

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Aubervilliers, France

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Beauvais, France

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Besançon, France

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Béziers, France

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Blois, France

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Bois-Bernard, France

...and 68 more locations