An open-label multi-center, multiple dose study to determine the optimum starting dose of intravenous MIRCERA for maintenance treatment of anemia in pediatric patients with chronic kidney disease on hemodialysis

Phase 1

Conditions: Chronic renal anemia
MedDRA version: 14.1Level: LLTClassification code 10058123Term: Renal anaemiaSystem Organ Class: 100000004851
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2007-007758-70-IT

Lead Sponsor: ROCHE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 41

Inclusion Criteria

1. Written informed consent 2. Pediatric patients 5 -17 years old with clinically stable chronic renal anemia 3. Hemodialysis treatment for at least 8 weeks 4. Body weight ≥ 10 kg 5. Adequate hemodialysis: URR of > 65% or Kt/V >1.2 for patients on thrice weekly HD. Patients with fewer or with more HD sessions per week should have a weekly Kt/V ≥ 3.6 6. Baseline pre-dialysis Hb concentration 10.0 - 12.0 g/dL determined from the mean of weekly Hb values measured between weeks -2 to -1 7. Intravenous maintenance epoetin alfa, epoetin beta, or darbepoetin alfa with same dosing interval for at least 8 weeks before screening 8. Stable maintenance epoetin alfa, epoetin beta, or darbepoetin alfa treatment with no weekly dose change ≥ 25% (increase or decrease) during the 2-weeks of screening. Patients who had been previously treated by the sc route could only participate if they have been receiving their ESA by the iv route for at least 8 weeks before screening. 9. Adequate iron status defined as serum ferritin ≥ 100 ng/mL or TSAT ≥ 20% (or percentage of hypochromic red cells < 10%); mean of two values measured during screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period 2. RBC transfusions within 8 weeks before screening or during the screening period 3. Hemoglobinopathies (e.g., omozygous sickle-cell disease, thalassemia of all types) 4. Hemolysis 5. Active malignant disease 6. Chronic, uncontrolled or symptomatic inflammatory disease (e.g. systemic lupus erythematosus) 7. Uncontrolled hypertension as assessed by the investigator 8. Epileptic seizures within 3 months prior to screening and during the screening period 9. Administration of any investigational drug within 4 weeks prior to screening and planned during the study 10. Severe hyperparathyroidism (Intact PTH ≥ 1000 pg/ml or whole PTH ≥ 500 pg/ml) or biopsy-proven bone marrow fibrosis 11. Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol, or to any constituent of the study drug formulation 12. Pure red cell aplasia (PRCA) or history of PRCA 13. High likelihood of early withdrawal or interruption of the study (e.g. planned living donor kidney transplant within 16 weeks after randomization) 14. Planned elective surgery during the entire study period (except hemodialysis access surgery)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: - To study the pharmacokinetics (PK) of MIRCERA in pediatric patients - To explore MIRCERA exposure response relationship - To assess the safety and tolerability of multiple doses of MIRCERA in pediatric patients - To document long-term safety and efficacy of MIRCERA administration in pediatric patients with anemia associated with CKD;Main Objective: - To determine the starting dose of MIRCERA in pediatric patients with CKD on hemodialysis when switching from stable maintenance treatment with epoetin alfa, epoetin beta or darbepoetin alfa - To demonstrate changes in Hb over time in response to different iv doses of MIRCERA;Primary end point(s): - Change in hemoglobin concentration between the baseline and evaluation periods (weeks 17-20)

Secondary Outcome Measures