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Prevention of End Stage Kidney Disease by Darbepoetin Alfa In CKD Patients With Non-diabetic Kidney Disease

Phase 3
20 Years
85 Years
Open (Enrolling)
Chronic Kidney Disease, Diabetes

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Trial Information

Prevention of End Stage Kidney Disease by Darbepoetin Alfa In CKD Patients With Non-diabetic Kidney Disease

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.

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 36000 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value.

Outcome Time Frame:

96 weeks

Safety Issue:



Japan: Institutinal Review Board, Showa University School of Medicine

Study ID:




Start Date:

December 2011

Completion Date:

December 2016

Related Keywords:

  • Chronic Kidney Disease
  • Diabetes
  • renal anemia
  • erythropoiesis stimulating agent
  • hemoglobin
  • non-diabetes
  • CKD
  • Chronic Kidney Disease patients without diabetes
  • Diabetes Mellitus
  • Kidney Diseases
  • Kidney Failure, Chronic
  • Renal Insufficiency, Chronic