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Completed

NCT Number: NCT02827266

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epoetin beta

Drug

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.

Other names: NeoRecormon and RO 205-3859

Primary outcomes

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

    Time frame: Week 8

Secondary outcomes

  1. Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Extension Phase

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Baseline, Week 8, 12

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

    Time frame: Week 8, 12

  5. Number of Participants With Local Injection Site Reactions

    Time frame: Up to 12 weeks

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

    Time frame: Up to 12 weeks

  7. Number of Participants With Chronic Kidney Disease

    Time frame: Baseline

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

    Time frame: Week 8

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

    Time frame: Week 8

  10. Response to Treatment at the end of the Correction Phase Among Participants With Different Hematocrit at Baseline

    Time frame: Week 8

  11. Number of Participants per Category of History of Medical Disorders and Surgical Procedures

    Time frame: Baseline

  12. Number of Participants per Type of Diabetes

    Time frame: Week 8, 12

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 11, 2016
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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