Phase 2
N=145
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
Chronic Kidney Disease · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01244763 ↗Enrolled (actual)
145
Serious AEs
24.1%
Results posted
Feb 2022
Primary outcome: Primary: Number (%) of Participants With an Hb Response by Week 17 — 19; 24; 21; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Roxadustat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kyntra Bio
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number (%) of Participants With an Hb Response by Week 17 |
19; 24; 21; 23; 23; 21 | — |
| SECONDARY Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 |
15; 14; 3; 13; 9; 9 | — |
| SECONDARY Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 |
9.56; 9.67; 9.80; 9.68; 9.89; 9.72 | — |
| SECONDARY Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 |
4; 11; 7; 8; 10; 7 | — |
| SECONDARY Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 |
4; 11; 5; 9; 8; 4 | — |
| SECONDARY Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 |
9; 11; 5; 8; 11; 10 | — |
| SECONDARY Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 |
6; 9; 10; 5; 6; 13 | — |
| SECONDARY Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL |
28.0; 28.0; 48.9; 28.0; 35.0; 56.0 | — |
| SECONDARY Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline |
21.0; 21.6; 42.0; 21.0; 35.0; 42.0 | — |
| SECONDARY Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline |
2.30; 2.50; 2.32; 2.36; 1.96; 1.61 | — |
| SECONDARY Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week |
11.49; 11.40; 11.32; 11.47; 11.62; 11.43 | — |
| SECONDARY Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories |
11.50; 18.75; 35.48; 14.03; 38.32; 32.56 | — |
| SECONDARY Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 |
15.23; 7.92; 25.65; 9.78; 9.17; 22.75 | — |
| SECONDARY Number (%) of Participants Requiring Rescue Therapy |
0; 2; 0; 1; 2; 0 | — |
| SECONDARY Number (%) of Participants Requiring Therapeutic Phlebotomy |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 |
5; 1; 0; 2; 1; 0 | — |
| SECONDARY Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) |
4.08; 4.13; 2.88; 4.17; 2.65; 3.02 | — |
| SECONDARY Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) |
2.99; 3.05; 2.73; 3.87; 2.09; 2.59 | — |
| SECONDARY Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 |
9.62; 9.56; 9.68; 9.58; 9.96; 9.75 | — |
Summary
The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 75 years
- Chronic kidney disease, not receiving dialysis
- Body weight 45 to 140 kg
Exclusion Criteria
- Any clinically significant infection or evidence of an underlying infection
- Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
- History of chronic liver disease
- New York Heart Association Class III or IV congestive heart failure
- Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
- History of malignancy
- Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
- History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
- History of hemosiderosis, hemochromatosis or polycystic kidney disease
- Active hemolysis or diagnosis of hemolytic syndrome
- Uncontrolled or symptomatic secondary hyperparathyroidism
- Seizure disorder or receiving anti-epilepsy medication
- Known bone marrow fibrosis
- Any prior or scheduled organ transplant
- Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor
- History of alcohol or drug abuse
Data sourced from ClinicalTrials.gov (NCT01244763). 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.