Chronic Kidney Disease, Diabetes
Conditions
Keywords
renal anemia, erythropoiesis stimulating agent, hemoglobin, non-diabetes, CKD, Chronic Kidney Disease patients without diabetes
Brief summary
The purpose of this study is to ask whether treating non-diabetic chronic kidney disease (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and 13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to 11g/dL.
Detailed description
Anemia is common among patients with chronic kidney disease (CKD) and is associated with an increased risk of cardiovascular and renal events. Although erythropoiesis stimulating agent (ESA) has been used to correct anemia, use of ESA (hemoglobin level at approximately 13 g/dL) did not reduce cardiovascular or renal events in diabetic CKD patients. Subgroup analysis of a recent randomized study suggested that use of darbepoetin alfa targeting Hb between 11 and 13 g/dL may preserve renal function better than targeting Hb between 9 and 11g/dL in non-diabetic CKD patients.
Interventions
DRUGDarbepoetin alfa
Darbepoetin alfa is used for targeting Hb level of 11-13g/dL in high Hb group, and 9-11g/dL in low Hb group.
Sponsors
Showa University School of Medicine
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. CKD patients who have not received chronic 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 8 weeks 4. CKD patients 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
1. Diabetes (treated, or HbA1c 6.4% IFCC) 2. CKD patients treated with ESA other than epoetins and darbepoetin. 3. CKD patients treated with epoetin 24000 IU/4w or more. 4. CKD patients treated with darbepoetin 90μg/4w or more. 5. Uncontrolled hypertension (180/10mmHg and higher) 6. Heart failure (NYHA III and IV) 7. malignancy, hematological disorder 8. malnutrition 9. Active and continuous gastrointestinal tract bleeding 10. ANCA associated glomerulonephritis, acute infection, active SLE 11. CKD patients who will undergo dialysis or receive transplantation within 6 months 12. Myocardial infarction within last 6 months 13. Stroke or pulmonary embolism within last 12 months 14. Severe allergy 15. Pregnant women, women on lactation, or CKD patients who plant to get pregnant 16. Allergy against erythropoetin 17. Ineligible patients according to the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value. | 96 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time from enrollment to initiation of dialysis | 96 weeks |
| Time from enrollment to 50% reduction of eGFR from initial value | 96 weeks |
| Time from enrollment to death by any cause | 96 weeks |
| Change of eGFR from enrollment | 96 weeks |
| Change of proteinuria/Cr ratio | 96 weeks |
| Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina. | 96 weeks |
| 50% renal survival | 96 weeks |
| Stroke | 96 weeks |
| Myocardial infarction | 96 weeks |
| Development of malignancy | 96 weeks |
| Number of Participants with Adverse Events baseline | 96 weeks |
| Renal protection in patients who maintained the target Hb more than half the time | 96 weeks |
Countries
Japan
Outcome results
None listed