Comparison · NCT01750190-cbf5650e
Roxadustat vs Placebo: Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Roxadustat vs Placebo: Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy. Trial comparisons, record NCT01750190-cbf5650e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01750190-cbf5650e
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.86 | 0.83 | 0.886 | wilson | |
| Risk in group 2 | 0.0656 | 0.0428 | 0.0991 | wilson | |
| Risk difference, group 1 minus group 2 | 0.795 | 0.75 | 0.829 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 13.1 | 8.58 | 20.1 | log | |
| Odds ratio, group 1 over group 2 | 87.7 | 52.8 | 146 | log | |
| Number needed to treat, for one more participant with the outcome on Roxadustat than on Placebo | 1.26 | 1.21 | 1.33 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Roxadustat | Participants received roxadustat tablets orally TIW. The initial dose was according to the tiered weight-based approach, with starting roxadustat doses of 70 mg TIW to participants weighing \<70 kg and roxadustat doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 234.9 weeks. | 523 | 608 | OG000 |
| Group 2 | Placebo | Participants received roxadustat-matching placebo tablets orally TIW. The initial dose was according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing \<70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) was performed based upon regular measurement of Hb levels until the participant achieved central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level was reached, the participant entered the maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration was 208.1 weeks. | 20 | 305 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy
- Description
The number of participants who achieved a Hb response at 2 consecutive visits at least 5 days apart during the first 24 weeks of treatment, without rescue therapy (that is, red blood cell \[RBC\] transfusion, erythropoiesis-stimulating agent \[ESA\], or intravenous \[IV\] iron) are reported. A Hb response is defined, using central laboratory values, as the following:~* Hb ≥11 g/dL and Hb increase from baseline by ≥1 g/dL in participants with baseline Hb \>8 g/dL, or~* An increase in Hb by ≥2 g/dL in participants with baseline Hb ≤8.0 g/dL
- Time frame
- Baseline up to Week 24
- Population
- FAS Population included of all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
- NCT number
- NCT01750190
- Phases
- PHASE3
- Conditions
- CKD Anemia
- Interventions
- Roxadustat, Placebo
- Lead sponsor
- Kyntra Bio
- Results first posted
- 2021-10-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01750190?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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