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

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ClinicalTrials.gov Identifier: NCT02827266
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Epoetin beta Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: NeoRecormon and RO 205-3859




Primary Outcome Measures :
  1. Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827266


  Show 78 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02827266     History of Changes
Other Study ID Numbers: ML18730
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics