Chronic Kidney Disease (CKD) Urological and Genital Diseases Kidney Disease
Conditions
Interventions
The intervention was administration of HMR4396, given subcutaneously 1, 2, or 3 times weekly for up to 52 weeks, starting at the same dose as the previous epoetin in three patient groups:
1. CKD not o
Sponsors
Hoechst Marion Roussel (Shire Pharmaceuticals) (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women, 18 years of age or older, with chronic renal failure 2. Evidence of anaemia (haemoglobin less than 11.0 g/dL) in medical history 3. Subjects receiving hemodialysis must have been prescribed to receive epoetin two or three times weekly by subcutaneous (s.c.) administration for at least 30 days immediately before signing informed consent 4. Predialysis subjects and subjects receiving peritoneal dialysis must have been prescribed to receive epoetin at least once weekly by s.c. administration for at least 30 days immediately before signing informed consent 5. Dose of epoetin not changed by more than 50% (increase or decrease) in the 30 days before signing informed consent 6. Haemoglobin 10.0 to 12.0 (±0.4) g/dL for the two weeks before receiving the first dose of HMR4396 as determined by one measurement per week 7. For predialysis subjects, serum creatinine greater than 2 mg/dL or creatinine clearance less than 45 mL/min as estimated by 24-hour urine collection or Cockcroft and Gault formula 8. Serum ferritin greater than or equal to 90 ng/mL and transferrin saturation greater than or equal to 18% as determined by the pre-study measurement
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypertension 2. For haemodialysis subjects, missed more than three dialysis sessions in the 30 days before signing informed consent 3. One or more doses of epoetin missed or withheld by physician order in the 14 days before signing informed consent 4. Concomitant unrelated illness that could reduce life expectancy to less than 12 months (such as malignancy, immune deficiency, myocardial infarction or cerebrovascular accident within 30 days before signing informed consent) 5. Thrombocytopenia (platelet count less than 75,000/mm^3) 6. Active bleeding 7. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) within 30 days before signing informed consent 8. Androgen therapy within 30 days before signing informed consent 9. Current drug abuse 10. Known Human Immunodeficiency Virus (HIV) infection from medical history 11. Treatment with any investigational drug within 30 days before signing informed consent 12. Breastfeeding 13. Pregnancy at enrolment or plans to become pregnant during the study. It was required that absence of pregnancy be documented by serum test before exposure to HMR4396 or any other study procedure with potential risk to a foetus 14. Childbearing potential. Absence of childbearing potential was defined as being surgically sterile, at least one year post-menopausal, or using a medically accepted (prescription or nonprescription) method of contraception 15. History of hypersensitivity to HMR4396 or to drugs with similar chemical structures 16. Impaired hepatic function, defined as a pre-study value for Aspartate Aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase [SGOT]) or Alanine Aminotransferase (ALT) (Serum Glutamic Pyruvic Transaminase [SGPT]) exceeding three times the upper limit of the normal range for the central laboratory 17. Clinically relevant haematologic, cardiovascular, hepatic, neurologic, endocrine, infectious, inflammatory or other major systemic disease making implementation of the protocol or interpretation of the study results difficult 18. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study 19. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study 20. Likelihood that the subject would require treatment during the study period with drugs not permitted by the protocol 21. Previous treatment with HMR4396
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint in this study was the determination of each subject?s average haemoglobin concentration (avHGB) over weeks 12, 16, 20, and 24. The primary efficacy analysis of avHGB was performed using the modified Intent-To-Treat (mITT) population. Additional analyses of the primary efficacy endpoint were conducted using the ITT and per-protocol populations. Efficacy analyses were conducted using haematology data collected up to seven days after the last held or received dose of study medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints included: 1. Mean treatment dose 2. Mean haematocrit 3. Percentage of haemoglobin values above 10 g/dL 4. Percentage of haematocrit values above 30% 5. Changes in weekly profiles of haemoglobin and haematocrit 6. Counts of red blood cells and reticulocytes Analyses of non-primary endpoints were conducted using both the modified Intent-To-Treat (mITT) and Intent-To-Treat (ITT) populations. | — |
Countries
France, Germany, United Kingdom, United States of America
Outcome results
None listed