PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease

• Status: Completed
• Trial end date: 2017-12-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Collaborator: Showa University School of Medicine
• Treatments: Darbepoetin alfa

Criteria

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