A Study to Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously For the Maintenance Treatment of Anemia in Pediatric Patients with Chronic Kidney Disease on Dialysis or Not yet on Dialysis

Phase 1

Conditions: Chronic renal anemia
MedDRA version: 20.0Level: LLTClassification code 10058132Term: Renal anemiaSystem Organ Class: 100000004851
MedDRA version: 20.0Level: LLTClassification code 10072870Term: Chronic anemiaSystem Organ Class: 100000004851
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2016-004779-39-HU

Lead Sponsor: F. Hoffmann-La Roche LTD.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Written informed consent from parent/legal guardian and willingness of parent/legal guardian to abide by the requirements of the study
- Written informed consent or assent from child where appropriate If required by national legislation, patients < 18 years of age at screening who are legally considered to be adults according to national legislation must consent in their own right
- Pediatric patients 3 months-17 years of age
- CKD with estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- For patients on PD: a weekly Kt/V >= 1.8
- For patients on hemodialysis (HD): adequate HD, urea reduction ratio (URR) > 65% or Kt/V > 1.2 for patients on HD three times per week
- Baseline hemoglobin (Hb) concentration 10.0-12.0 g/dL determined from the mean of two Hb values measured at Visit 1 and Visit 2
- Stable SC maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa with the same dosing interval for at least 6 weeks before the first dose of Mircera
- Stable dose of epoetin alfa, epoetin beta, or darbepoetin alfa treatment with no weekly dose change > 25% (increase or decrease) for at least 4 weeks before the first dose of Mircera
- Adequate iron status
- For post-pubertal female patients of childbearing potential: agreement to remain abstinent or to use acceptable contraceptive methods during the study and for 90 days after the last dose of Mircera
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
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

- Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
- RBC transfusions within 8 weeks before screening or during the screening period
- Hemoglobinopathies
- Hemolytic anemia
- Active malignant disease
- PD subjects with an episode of peritonitis within the past 30 days prior to screening and/or during the screening period
- Uncontrolled or symptomatic inflammatory disease
- Uncontrolled hypertension as assessed by the investigator
- Epileptic seizures within 3 months prior to screening and during the screening period
- Administration of any investigational drug within 4 weeks prior to screening or planned during the study
- Severe hyperparathyroidism or biopsy-proven bone marrow fibrosis
- Known hypersensitivity to recombinant human erythropoietin(EPO), polyethylene glycol, or any constituent of the study drug formulation
- Anti-EPO antibody (AEAB)-mediated pure red cell aplasia (PRCA) or history of AEAB-mediated PRCA or positive AEAB test result in the absence of PRCA
- High likelihood of early withdrawal or interruption of the study
- Planned elective surgery during the entire study period
- Females who are pregnant or breastfeeding or who intend to become pregnant during the study or within 90 days after the last dose of Mircera
- Patients of childbearing potential must have a negative serum pregnancy test result within 21 days prior to initiation of study drug

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To ascertain the starting dose of Mircera given subcutaneously in pediatric patients CKD on dialysis or not yet on dialysis when switching from stable SC maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa;Secondary Objective: • To assess the safety and tolerability of multiple doses of Mircera given subcutaneously in pediatric patients<br>• To evaluate the pharmacokinetics(PK) and the pharmacodynamics(PD) of Mircera in patients on dialysis or not yet on dialysis who receive the study medication by the Subcutaneous(SC) route of administration<br>;Primary end point(s): Change in Hb concentration (g/dL) between the baseline and the evaluation period for each patient;Timepoint(s) of evaluation of this end point: Up to Week 45

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1-6. Up to Week 45<br>7. Week 1, Week 3, Week 9, Week 17, Week 19;Secondary end point(s): 1. Number of patients with an average Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb or above, within or below the range of 10-12 g/dL<br>2. Change in Mircera dose over time, including the change between the starting dose and the evaluation period<br>3. Occurrence and severity of adverse events<br>4. Change from baseline in targeted vital signs<br>5. Change from baseline in targeted clinical laboratory test results<br>6. Hb concentrations<br>7. Serum concentrations of Mircera

Related Trials