Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin for Treatment of Anemia in Children With Chronic Kidney Disease

• Status: Completed
• Trial end date: 2019-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The present study was designed to determine whether or not darbepoetin alfa is non-inferior to recombinant human erythropoietin in the treatment of anemia in children with chronic kidney disease stage 3-5 (on or not on dialysis).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rufaida Mazahir
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

Inclusion Criteria:

1. Age 1-18 years.

2. CKD patients stages 3 to 5 (on or not on dialysis).

3. Baseline hemoglobin 9 - 12 g/dL.

4. Subject should have adequate transferrin saturation (≥20%) and serum ferritin (≥100 ng/mL).

5. Stable erythropoietin therapy for 8 weeks ( defined as a ≤25% change in prescribed dose, no change in the route of administration and no more than one missed or withheld dose).

Exclusion Criteria:

1. Subject scheduled for a living-related kidney transplant.

2. Subject with uncontrolled hypertension.

3. HIV positive patient.

4. The patient with known hematologic disease or cause of anemia other than renal disease.

5. Patient with a history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrolment.

6. Hyperparathyroidism (Intact parathyroid hormone more than 1500 pg/ml or biopsy proven marrow fibrosis).

7. Major surgery within 12 weeks.

8. Active inflammatory disease within 8 weeks of randomization requiring immunosuppressive therapy.

9. Clinical evidence of malignancy.

10. Blood transfusion within 8 weeks prior to initiation of therapy.