Phase 4
Completed N=206
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
Chronic Kidney Diseases · Iron Deficiency Anemia
Source: ClinicalTrials.gov NCT03236246 ↗
Enrolled (actual)
206
Serious AEs
24.9%
Results posted
Mar 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin (Hgb) at Week 24 — 0.73; 0.70 grams per deciliter (g/dL)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin (Hgb) at Week 24 |
0.73; 0.70 | — |
| SECONDARY Change From Baseline in Hgb at Week 48 |
0.61; 0.58 | — |
| SECONDARY 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 |
84.0; 57.0 | — |
| SECONDARY Change From Baseline in Transferrin Saturation (TSAT) at Week 24 |
6.30; 6.85 | — |
| SECONDARY Change From Baseline in TSAT at Week 48 |
7.97; 10.63 | — |
| SECONDARY Change From Baseline in Ferritin at Week 24 |
136.63; 155.28 | — |
| SECONDARY Change From Baseline in Ferritin at Week 48 |
251.44; 343.27 | — |
| SECONDARY Change From Baseline in Serum Phosphate at Week 24 |
-0.19; -0.25 | — |
| SECONDARY Change From Baseline in Serum Phosphate at Week 48 |
-0.07; -0.20 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 |
-1.08; -1.53 | — |
| SECONDARY Change From Baseline in eGFR at Week 48 |
-1.85; -2.20 | — |
| SECONDARY Change From Baseline in Bicarbonate at Week 24 |
-0.15; -0.05 | — |
| SECONDARY Change From Baseline in Bicarbonate at Week 48 |
0.03; -0.51 | — |
| SECONDARY Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24 |
1.64; 0.39 | — |
| SECONDARY Change From Baseline in iPTH at Week 48 |
-1.49; 5.74 | — |
| SECONDARY Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24 |
-94.78; -63.22 | — |
| SECONDARY Change From Baseline in C-terminal FGF23 at Week 48 |
-85.70; -80.34 | — |
| SECONDARY Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24 |
-0.23; -2.01 | — |
| SECONDARY Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48 |
18.52; 10.15 | — |
| SECONDARY 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 |
0.00; -3.19; -15.00; 4.00; -15.00; 1.40 | — |
| SECONDARY Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures |
0.00; -3.48; -11.43; 7.78; -11.43; 4.71 | — |
| SECONDARY Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment |
-18.03; -6.34 | — |
| SECONDARY Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment |
-16.71; -6.72 | — |
| SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24 |
7.22; 4.35 | — |
| SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48 |
7.49; 3.68 | — |
| SECONDARY Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period |
13; 10 | — |
| SECONDARY Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period |
4.08; 3.91 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period |
89; 89 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03236246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.