Chronic Kidney Dosease patients without diabetes
Conditions
Interventions
High Hb group Targeting Hb is 12g/dL and keep maintaining Hb 11.og/dL and higher and less than 13.0g/dL. If the patients do not have medical histry of myocardial infarction, stroke, plumonary emboli
Sponsors
PREDICT steering committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) CKD patients who have notchronically treated with dialysis 2) eGFR 8 and more and less than 20 mL/min/1.73m2 determined twice in last 12 weeks. 3) CKD patients with renal anemia at Hb less than 10g/dL within last 4 weeks 4) CKD patiens with TSAT 20% and higher or serum ferritin 100ng/mL and higher. 5) CKD patients treated with standard care 6) CKD patients provided written informed consent.
Exclusion criteria
Exclusion criteria: 1) Diabetes (HbA1c 6.4% IFCC) 2) CKD patients treated with ESA other than epoetins. 3) CKD patients treated with epoetin 36000 IU or more. 4) Hypertension (180/10mmHg and higher) 5) Heart failure (NYHA III and IV) 6) malignancy, hematological disorder 7) malnuturition 8) Active and continuous gastrointestinal tract bleeding 9) ANCA associated glomerulonephritis, acute infection, active SLE 10) CKD patients who will be started dialysis or will receive tranplantation 11) Myocardial infarction within last 6 months 12) Stroke or plumonary embolism within last 12 months 13) Severe allergy 14) Pregnant woman or CKD patients who wish to be pregnant 15) Allergy against erythropoetin 16) CKD patients who is not appropriate to entry the clincal trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, and eGFR less than 50% of intial value. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, amputation above foot, admission by heart failure or angina. 2) Time from enrollment to initiation of dialysis 3) Time from enrollment to 50% reduction of eGFR from initial value 4) Time from enrollment to death bu any cause 5) Change of eGFR from enrollment 6) Change of proteinuria/Cr ratio. 7) Per protocol analysis of patients targeted Hb value maintained more than 50%. 8) Time from intiation to 50% reduction of eGFR from enrollment. 9) Event of stroke 10) Event of myoxardial infarction 11) Event of development of malignancy | — |
Countries
Japan
Contacts
Public ContactENYU IMAI
Nakayamadera Imai Clinic Nephrology
Outcome results
None listed