Comparison · NCT01750190-d17e96bb
Roxadustat vs Placebo: Number (%) of Participants Who Experienced Exacerbation of Hypertension
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 Who Experienced Exacerbation of Hypertension. Trial comparisons, record NCT01750190-d17e96bb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01750190-d17e96bb
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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 | 0.23 | 0.199 | 0.265 | wilson | |
| Risk in group 2 | 0.157 | 0.121 | 0.202 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0729 | 0.0178 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.46 | 1.09 | 1.97 | log | |
| Odds ratio, group 1 over group 2 | 1.6 | 1.12 | 2.3 | log | |
| Number needed to treat, for one more participant with the outcome on Roxadustat than on Placebo | 13.7 | 8.09 | 56.3 | 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. | 140 | 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. | 48 | 305 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number (%) of Participants Who Experienced Exacerbation of Hypertension
- Description
Exacerbation of hypertension was defined as an increase from baseline of ≥20 millimeter of mercury (mmHg) in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mmHg in diastolic blood pressure (dBP) and dBP ≥110 mmHg.
- Time frame
- Baseline up to Week 52
- Population
- FAS Population included 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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