An Open Label, Single Arm, Multicenter Study to Ascertain the Optimal Starting Dose of Mircera
Study ID: STU 022018-037
This study is an open label, single arm, multicenter study to ascertain the optimal starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric patients with CKD on dialysis or not yet on dialysis. Following written informed consent from a parent or legal guardian and, if appropriate, assent from the child, the patient will be screened for eligibility during a 3-week period. During this period, patients will continue to receive epoetin alfa, epoetin beta, or darbepoetin alfa at the same weekly dose, route SC, and interval as before screening. The total weekly doses 4 weeks before the first Mircera administration should not change, increase or decrease. Provided that all eligibility criteria are met, including those for hemoglobin levels and iron status, the patients will start Mircera administered subcutaneously. The primary endpoint will be the change in Hb concentration (g/dL) between the baseline and the evaluation period for each patient. This is calculated on a per-patient basis, using an area under the curve approach to calculate an individual's average for both the baseline and evaluation periods and taking the difference.
Inclusion Criteria Patients must meet the following criteria for study entry: * 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 with clinically stable chronic renal anemia * CKD with estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2 (determined by the Bedside Schwartz formula) or dialysis treatment for at least 8 weeks before the first dose of Mircera * For patients on peritoneal dialysis (PD): a weekly Kt/V >= 1.8 * For patients on HD: adequate HD, urea reduction ratio (URR) > 65% or Kt/V > 1.2 for patients on HD three times per week. Patients with fewer than or more than three HD sessions per week should have a weekly Kt/V >= 3.6. * Baseline Hb concentration 10.0 - 12.0 g/dL determined from the mean of two Hb values measured at Visit 1 (Week - 3) and Visit 2 (Week - 1) * 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 defined as ferritin >=100 ng/mL or transferrin saturation (TSAT) >= 20% (or percentage of hypochromic red cells < 10%); mean of two values measured during screening * For post-pubertal female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use acceptable contraceptive methods during the study and for 90 days after the final dose of Mircera A female patient is considered to be of childbearing potential if she is postmenarcheal. The following are acceptable contraceptive methods: hormonal contraceptives; hormone-releasing intrauterine devices; copper intrauterine devices; male or female condom with or without spermicide cap, diaphragm, or sponge with spermicide. * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- RAYMOND PHILLIP QUIGLEY
F. HOFFMANN-LA ROCHE LTD
This study will ascertain the 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 when switching from stable subcutaneous maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa. Most patients with CKD undergoing HD or PD require continuous long-term treatment with eSas to correct anemia and to maintain anemia correction. The Sponsor has completed Phase ii and iii studies of Mircera and has shown that it is safe and effective in the treatment of anemia in adult patients not yet on dialysis and in those patients receiving HD or PD. Furthermore, Study nH19707 has shown that pediatric patients with CKD on HD can be safely and effectively switched from maintenance treatment with iV epoetin alfa, epoetin beta, or darbepoetin to Mircera iV using CFs to define the starting dose. The purpose of this study is to use the same CFs to ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia with SC eSas in pediatric patients with CKD on dialysis or not yet on dialysis. The study design is based on the study design of nH19707 but with fewer visits, as patients on PD or not yet on dialysis visit the nephrology centers less frequently than patients on HD. The similar study design will allow pooling of the data from the two pediatric studies.