Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease Clinical Trial
Official title:
A 24-Week, Open-Label, Randomized, 2-Arm Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).
| Status | Not yet recruiting |
| Enrollment | 36 |
| Est. completion date | March 2027 |
| Est. primary completion date | January 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 18 Years |
| Eligibility | Inclusion Criteria: - Age 6 years to <18 years at Screening - Body Weight =12 kilograms (kg) at Screening - Chronic kidney disease (CKD) stage 3 to 5, not on dialysis, with estimated glomerular filtration rate (eGFR) <60 milliliters per minute (mL/min)/1.73 meters squared (m^2) utilizing the "Bedside Schwartz" equation - Hemoglobin (Hgb) =8.5 and =11.5 grams per deciliter (g/dL) at Screening - Transferrin saturation (TSAT) =25% at Screening - Ferritin =200 nanograms per milliliter (ng/mL) at Screening Exclusion Criteria: - Serum phosphorus level at Screening: - 6 to <13 years: =4.0 milligrams per deciliter (mg/dL); - 13 to <18 years: =2.7 mg/dL - Liver transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) ?3× the upper limit of normal at Screening - Active significant gastrointestinal (GI) disorder, including overt gastrointestinal (GI) bleeding or active inflammatory bowel disease - Unable to swallow pills - Anemia due to causes other than iron deficiency anemia (IDA) of CKD - Intravenous iron therapy or blood transfusion within 4 weeks before the Screening visit - Participants with a functioning organ transplant - Receipt of any investigational drug within 4 weeks before Screening - Phosphate binder use during the Screening period |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Keryx Biopharmaceuticals |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events | up to Week 28 | ||
| Primary | Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results | up to Week 24 | ||
| Primary | Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate | up to Week 28 | ||
| Secondary | Change from Baseline in Hemoglobin to Week 24/Early Termination Visit | Baseline; Week 24 | ||
| Secondary | Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit | Baseline; Week 24 | ||
| Secondary | Change from Baseline in Ferritin to Week 24/Early Termination Visit | Baseline; Week 24 | ||
| Secondary | Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit | Baseline; Week 24 | ||
| Secondary | Change from Baseline in Calcium to Week 24/Early Termination Visit | Baseline; Week 24 | ||
| Secondary | Change from Baseline in Bicarbonate to Week 24/Early Termination Visit | Baseline; Week 24 |