None listed
Conditions
Interventions
ALL SUBJECTS, REGARDLESS OF TREATMENT ASSIGNMENT, WILL RECEIVE STANDARD OF CARE WITH VITAMIN D STEROLS (CALCITRIOL AND ITS ANALOGS).
IN ADDITION TO THE STANDARD OF CARE, IN THE DOUBLE-BLIND PHASE,
Sponsors
AMGEN INC.,
Eligibility
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. AGE 6 TO LESS THAN 18 YEARS AT SCREENING. 2. DIAGNOSED WITH CKD AND SHPT RECEIVING HD OR PD FOR ≥ 2 MONTHS BEFORE RANDOMIZATION. 3. DRY WEIGHT ≥ 12.5 kg AT SCREENING. 4. iPTH OBTAINED FROM THE CENTRAL LABORATORY MUST BE ≥ 350 pg/mL (37.1 pmol/L). 5. SERUM CALCIUM (CORRECTED) OBTAINED FROM THE CENTRAL LABORATORY MUST BE ≥ 8.8 mg/dL (2.2 mmol/L). 6. SERUM PHOSPHORUS OBTAINED FROM THE CENTRAL LABORATORY ≥ 4.0 mg/dL (1.3 mmol/L) FOR CHILDREN 6 TO LESS THAN 12 YEARS OLD, OR ≥ 3.5 mg/dL (1.1 mmol/L) FOR CHILDREN 12 TO LESS THAN 18 YEARS OLD. 7. FOR SUBJECTS ALREADY RECEIVING VITAMIN D STEROLS (EITHER CALCITRIOL OR A SYNTHETIC ANALOG HEREOF), A STABLE DOSE DEFINED AS NO CHANGE > 50% WITHIN THE PRECEDING 2 MONTHS FROM RANDOMIZATION. 8. FOR SUBJECTS TAKING GROWTH HORMONE, A STABLE DOSE DEFINED AS NO CHANGE > THAN 20% WITHIN THE PRECEDING 2 MONTHS PRIOR TO RANDOMIZATION. 9. SUBJECTS ON ANTI-CONVULSANT MEDICATION MUST BE ON A STABLE DOSE FOR 3 MONTHS, AND HAVE A THERAPEUTIC BLOOD LEVEL OF THE ANTI-CONVULSANT AT THE TIME OF RANDOMIZATION.
Exclusion criteria
Exclusion criteria: 1. AN UNSTABLE MEDICAL CONDITION IN THE JUDGMENT OF THE INVESTIGATOR. 2. UNDERWENT PARATHYROIDECTOMY IN THE 6 MONTHS BEFORE THE DATE OF RANDOMIZATION. 3. ANTICIPATED PARATHYROIDECTOMY WITHIN 6 MONTHS AFTER RANDOMIZATION. 4. RECEIVED THERAPY WITH CINACALCET WITHIN 1 MONTH PRIOR TO RANDOMIZATION. 5. A NEW ONSET OF SEIZURE OR WORSENING OF A PRE-EXISTING SEIZURE DISORDER WITHIN 6 MONTHS PRIOR TO FIRST DOSE OF IP. 6. SCHEDULED DATE FOR KIDNEY TRANSPLANT FROM A KNOWN LIVING DONOR THAT MAKES COMPLETION OF THE STUDY UNLIKELY. GENERAL: 7. CURRENTLY ENROLLED IN ANOTHER INVSTIGATIONAL DEVICE OR DRUG STUDY, OR LESS THAN 30 DAYS SINCE ENDING ANOTHER INVESTIATIONAL DEVICE OR DRUG STUDY(S), OR RECEIVING OTHER INVESTIGATIONAL AGENT(S). 8. IF SEXUALLY ACTIVE, SUBJECT IS NOT WILLING TO USE HIGHLY EFFECTIVE CONTRACEPTION DURING TREATMENT AND FOR AT LEAST ONE MONTH (FEMALES) AND 3 MONTHS (MALES) AFTER THE END OF TREATMENT. 9. PATIENTS PREGNANT OR NURSING, OR PLANNING TO BECOME PREGNANT OR STUDY DURING THE MONTH FOLLOWING THE END OF TREATMENT.
Countries
Australia, Belgium, Germany, Hungary, Mexico, Poland, Russian Federation, Slovakia, Spain, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed