diabetic and transplanted CKD stage III patients MedDRA version: 16.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 100000004857
Conditions
Interventions
Trade Name: MIRCERA®
Product Name: C.E.R.A.
Product Code: RO0503821
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
Current Sponsor code: RO05
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willingness to give written informed consent, written consent for data collection ("Datenschutzrechtliche Einwilligung") and willingness to participate and to comply with the study protocol 2. Adult patients (=18 years) 3. For diabetic patients: Type 2 diabetes mellitus with HbA1c > 7% or anti-diabetic treatment (Two values from medical routine =65 years) yes F.1.3.1 Number of subjects for this age range 108
Exclusion criteria
Exclusion criteria: 1. Hb-level 14 g/dL (value from local measurement at screening) 2. Average SBP > 140 mm Hg or average DBP > 90 mm Hg (Value from medical routine 9% 6. Documented and suspected gastrointestinal bleeding within 8 weeks before inclusion 7. Reasons for subnormal Hb-levels between 11-14 g/dL other than impaired kidney function 8. Myocardial infarction or stroke in the 6 months prior to inclusion 9. Severe and instable coronary artery disease (CAD) 10. Manifest chronic congestive heart failure (New York Heart Association Class III to IV) 11. Epileptic seizures in the 6 months prior to inclusion 12. RBC transfusions within 2 months before inclusion 13. Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) 14. Hemolysis 15. Active malignant disease i.e. disease free survival for less than 5 years, except non-melanoma skin cancer. Basal cell carcinoma of the skin under curative treatment is not considered as active malignant disease. 16. Chronic, uncontrolled or symptomatic inflammatory disease (e.g. rheumatoid arthritis, systemic lupus erythematodes) 17. Acute infection or sepsis 18. CRP > 15 mg/L 19. Apparent vitamin B12 deficiency despite adequate treatment 20. Apparent folic acid deficiency despite adequate treatment 21. Pure red cell aplasia or a history of PRCA 22. Platelets > 500 x 109/L or < 100 x 109/L 23. Antidiabetic treatment with glitazones 24. Planned elective surgery (except laser photocoagulation, cataract and vascular access surgery) 25. Apparent life expectancy less than 24 months 26. Treatment with an ESA within the last 6 months prior to inclusion 27. Patients who received an additional organ transplant, other than kidney 28. Transplanted patients with previous (last 6 months) or active mTOR (Sirolimus, Everolimus) based immunosuppressive regimen 29. Present and known Hepatitis B - infection 30. Patients suffering from recurrence of original renal disease (e.g. IgA-nephropathy, FSGS) 31. Patients with relevant stenosis of the renal artery 32. Administration of any investigational drug within 30 days (or five times the half life of this investigational drug, independent of verum or placebo treatment) preceding the study start. Investigational drug is defined as any material (placebo or drug) dispensed under the provision of a study protocol 33. Patients who have received any investigational drug under the provision of this protocol 34. Patients currently in treatment or interventional follow up of another clinical trial 35. Women lactating, pregnant or of childbearing potential not using a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1 % per year, are implants, injectables, combined oral contraceptives, IUDs (only hormone spirals), sexual abstinence or vasectomized partner) 36. Positive pregnancy test (serum, ß-HCG) at screening/visit 0 37. Known hypersensitivity to epoetin beta or any constituents of the Mircera® formulation 38. Patients who are
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate if treatment with methoxy polyethylene glycol-epoetin beta has a protective effect on the kidney of CKD stage III patients. This renoprotective influence will be defined as a slowing of disease progression, reflected by the yearly decline of GFR. The GFR will be estimated based on serum creatinine using the 4-variable-MDRD formula. All laboratory parameters, including serum creatinine, will be analyzed by a central laboratory to ensure homogenous results.;Secondary Objective: Secondary objective includes the assessment of whether an effect on urinary protein creatinine ratio, serum creatinine and cystatine C can be disclosed and if there are differences between patients pre-dialysis and post-kidney-Tx (who fulfill the CKD-criteria). Furthermore, safety parameters concerning adverse events – especially drop out due to increase of Hb, drop out due to increase of blood pressure, anti-erythropoietin antibodies and acute rejection - will be captured.;Primary end point(s): Change in eGFR over time (MDRD equation, 4 variables);Timepoint(s) of evaluation of this end point: 04/2014 04/2015 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change of UACR Change in serum creatinine Change in serum cystatin C Adverse events Drop out due to increase in Hb Drop out due to increase in blood pressure Appearance of anti erythropoietin antibodies Acute rejection ;Timepoint(s) of evaluation of this end point: 04/2015 | — |
Countries
Germany
Contacts
Public ContactCountry Study Manager
Roche Pharma AG
Outcome results
None listed