Comparison · NCT01750190-af751818
Roxadustat vs Placebo: Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With 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: Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy. Trial comparisons, record NCT01750190-af751818. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01750190-af751818
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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 | 0.768 | 0.733 | 0.8 | wilson | |
| Risk in group 2 | 0.184 | 0.144 | 0.231 | wilson | |
| Risk difference, group 1 minus group 2 | 0.584 | 0.526 | 0.635 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.18 | 3.29 | 5.32 | log | |
| Odds ratio, group 1 over group 2 | 14.7 | 10.4 | 20.8 | log | |
| Number needed to treat, for one more participant with the outcome on Roxadustat than on Placebo | 1.71 | 1.57 | 1.9 | 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. | 467 | 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. | 56 | 305 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy
- Description
Hb values under the influence of a rescue therapy were censored by Cochran-Mantel-Haenszel Test for up to 6 weeks. Responder was defined as: Hb ≥10.0 g/dL, which was based on central laboratory values.
- Time frame
- Weeks 28 to 36
- Population
- FAS Population consisted 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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