Phase 2
Completed N=35
Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
Source: ClinicalTrials.gov NCT00761657 ↗Enrolled (actual)
35
Serious AEs
4.3%
Results posted
Nov 2021
Primary outcomePrimary: Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) — 3; 9; 7; 5 Participants
Summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) |
3; 9; 7; 5; 9; 7 | — |
| PRIMARY Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) |
10.32; 10.03; 9.18; 10.35; 10.28; 10.08 | 0.2073 |
| PRIMARY Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) |
10.32; 10.03; 9.18; 10.35; 10.28; 10.08 | 0.0507 |
| SECONDARY Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) |
1; 6; 1; 1; 8; 10 | — |
| SECONDARY Plasma Roxadustat Concentration (Part 2) |
394.800; 260.027; 422.700; 28.596; 168.310; 283.067 | — |
| SECONDARY Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 |
13.46; 13.30; 9.00; 8.50; 13.75; -1.50 | — |
| SECONDARY Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 |
8.30; 9.55; 10.45; 2.80; 2.10; 1.00 | — |
Eligibility Criteria
Inclusion Criteria
- 18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader.
- Chronic Kidney Disease Stage 3 or 4 with hemoglobin 110 millimeter of mercury (mmHg) or systolic BP >170 mmHg at screening).
- New York Heart Association Class III or IV congestive heart failure.
- Recent myocardial infarction or acute coronary syndrome.
- History of myelodysplastic syndrome.
- Any history of malignancy or a known genetic predisposition for developing cancer (for example, with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.
- Active inflammatory infection or chronic inflammatory disease.
- Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
- Blood clots within 4 weeks.
- History of ongoing hemolysis or diagnosis of hemolytic syndrome.
- Known history of bone marrow fibrosis.
- History of hemosiderosis or hemochromatosis.
- Androgen therapy within 12 weeks.
- Red blood cell transfusion within 12 weeks.
- Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
- Intravenous iron supplementation within the past 60 days.
- Currently taking dapsone or acetaminophen >2.6 g/day.
- History of prior organ transplantation.
- Alcohol consumption greater than 3 or more drinks per day within the past year.
- Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
- Positive urine toxicology screen for a substance that has not been prescribed for the participant.
Data sourced from ClinicalTrials.gov (NCT00761657). 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.