NCT03236246CompletedPhase 4
Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia
Keryx Biopharmaceuticals24 sites in 1 country206 target enrollmentStarted: August 15, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Keryx Biopharmaceuticals
- Enrollment
- 206
- Locations
- 24
- Primary Endpoint
- Change From Baseline in Hemoglobin (Hgb) at Week 24
Study Overview
Brief Summary
The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).
Detailed Description
This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min
- •Hgb ≥8.5 g/dL and ≤11.5 g/dL
- •Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
- •Serum intact parathyroid hormone ≤600 pg/mL
Exclusion Criteria
- •Serum phosphate <3.0 mg/dL
- •Intravenous (IV) iron administered within 4 weeks prior to Screening
- •Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
- •Blood transfusion within 4 weeks prior to Screening
Arms & Interventions
Group 1
Experimental
KRX-0502 1 tablet thrice daily (TID) with meals
Intervention: KRX-0502 (Drug)
Group 2
Experimental
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
Intervention: KRX-0502 (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin (Hgb) at Week 24
Time Frame: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Secondary Outcomes
- Change From Baseline in Hgb at Week 48(Baseline; Week 48)
- Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment(Baseline; Week 24)
- Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment(Baseline; Week 48)
- Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures(Baseline; Week 24)
- Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures(Baseline; Week 48)
- Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period(up to Week 48)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period(up to Week 48)
- Change From Baseline in Ferritin at Week 24(Baseline; Week 24)
- Change From Baseline in Ferritin at Week 48(Baseline; Week 48)
- Change From Baseline in Serum Phosphate at Week 48(Baseline; Week 48)
- Change From Baseline in TSAT at Week 48(Baseline; Week 48)
- Change From Baseline in Serum Phosphate at Week 24(Baseline; up to Week 24)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24(Baseline; Week 24)
- Change From Baseline in Bicarbonate at Week 24(Baseline; Week 24)
- Change From Baseline in Bicarbonate at Week 48(Baseline; Week 48)
- Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24(Baseline; Week 24)
- Change From Baseline in eGFR at Week 48(Baseline; Week 48)
- Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24(Baseline; Week 24)
- Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48(Baseline; Week 48)
- Change From Baseline in iPTH at Week 48(Baseline; Week 48)
- Change From Baseline in C-terminal FGF23 at Week 48(Baseline; Week 48)
- Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48(Baseline; Week 48)
- Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period(up to Week 48)
- Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period(from Randomization to Week 24)
- Change From Baseline in Transferrin Saturation (TSAT) at Week 24(Baseline; Week 24)
- Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24(Baseline; Week 24)
- Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24(Baseline; Week 24)
Investigators
Study Sites (24)
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