EUCTR2009-015114-22-DE进行中（未招募）不适用
A randomized controlled, single-blind, proof- of- concept-study to investigate the protective effects of early treatment with C.E.R.A. in patients with chronic kidney disease on renal disease progression (PRIMAVERA-Study) - Primavera
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 < 1 year prior Screening or measured by central laboratory at Screening Visit)
- •4. For renal allograft recipients: Status at least 6 months post Tx
- •5. CKD Stage III (eGFR between 30-59 ml/min/1.73 m2 (MDRD equation, 4 variables)) (Value from medical routine < 1 month prior Screening or measured by central laboratory at Screening Visit)
- •6. UACR < 3000 mg/g creatinine or total protein < 3000 mg/24h urine sample where applicable (Values from medical routine < 3 months prior Screening or measured by the central laboratory at Screening Visit)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 132
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 108
排除标准
- •1. Hb-level < 11 or > 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 < 1 month prior Screening. Average of two measurements with a 1 to 5 min. interval, taken with the patient sitting (or standing: for elderly subjects, diabetic patients, or when postural hypotension may be frequent))
- •3. Initiation of ACEI or ARB or aliskiren treatment less than 3 months before screening.
- •4. Present and known iron deficiency measured with the parameters serum ferritin and TSAT (despite adequate treatment)
- •5. HbA1c >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
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