Trial · NCT01244763
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
NCT01244763, Phase 2, Completed, Kyntra Bio; results first posted 2022-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia. Trials, record NCT01244763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01244763
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
- NCT number
- NCT01244763
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 145 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- Chronic Kidney Disease, Anemia
- Interventions
- Roxadustat
- First posted
- 2010-11-19
- Last updated
- 2022-02-10
- Results first posted
- 2022-02-10
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number (%) of Participants With an Hb Response by Week 17 | Up to Week 17 | An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL. |
| Secondary | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL. |
| Secondary | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | Baseline is defined as the mean of the last 3 available values predose. |
| 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 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive. |
| 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 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | |
| 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 | Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks. |
| 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 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | |
| Secondary | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) | Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved. |
| Secondary | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F) | Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved. |
| Secondary | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number (%) of Participants With an Hb Response by Week 17 | Up to Week 17 | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | g/dL | MEAN |
| 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 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. | days | MEDIAN |
| SECONDARY | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. | days | MEDIAN |
| SECONDARY | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. | mg/kg/week | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group1,062
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number (%) of Participants With an Hb Response by Week 17 | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | 19 | Participants | ||
| Number (%) of Participants With an Hb Response by Week 17 | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | 24 | Participants | ||
| Number (%) of Participants With an Hb Response by Week 17 | Cohort C: Roxadustat at 50 mg TIW | 21 | Participants | ||
| Number (%) of Participants With an Hb Response by Week 17 | Cohort D: Roxadustat at 100 mg TIW | 23 | Participants | ||
| Number (%) of Participants With an Hb Response by Week 17 | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | 23 | Participants | ||
| Number (%) of Participants With an Hb Response by Week 17 | Cohort F: Roxadustat at 70 mg BIW Then QW | 21 | Participants | ||
| Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Week 5 | 15 | Participants | |
| Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Week 5 | 14 | Participants | |
| Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Cohort C: Roxadustat at 50 mg TIW | Week 5 | 3 | Participants | |
| Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Cohort D: Roxadustat at 100 mg TIW | Week 5 | 13 | Participants |
1 to 10 of 1,062Source ClinicalTrials.gov
See all 1,062 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | 24 | |
| Overall Study | STARTED | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | 24 | |
| Overall Study | STARTED | Cohort C: Roxadustat at 50 mg TIW | 24 | |
| Overall Study | STARTED | Cohort D: Roxadustat at 100 mg TIW | 24 | |
| Overall Study | STARTED | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | 24 | |
| Overall Study | STARTED | Cohort F: Roxadustat at 70 mg BIW Then QW | 25 | |
| Overall Study | Safety Population | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | 24 | |
| Overall Study | Safety Population | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | 24 | |
| Overall Study | Safety Population | Cohort C: Roxadustat at 50 mg TIW | 24 | |
| Overall Study | Safety Population | Cohort D: Roxadustat at 100 mg TIW | 24 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events306
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary Tract Infection | Infections and infestations | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | 0 | 24 | |
| other | Urinary Tract Infection | Infections and infestations | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | 4 | 24 | |
| other | Urinary Tract Infection | Infections and infestations | Cohort C: Roxadustat at 50 mg TIW | 2 | 24 | |
| other | Urinary Tract Infection | Infections and infestations | Cohort D: Roxadustat at 100 mg TIW | 1 | 24 | |
| other | Urinary Tract Infection | Infections and infestations | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | 4 | 24 | |
| other | Urinary Tract Infection | Infections and infestations | Cohort F: Roxadustat at 70 mg BIW Then QW | 3 | 25 | |
| other | Nasopharyngitis | Infections and infestations | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | 2 | 24 | |
| other | Nasopharyngitis | Infections and infestations | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | 2 | 24 | |
| other | Nasopharyngitis | Infections and infestations | Cohort C: Roxadustat at 50 mg TIW | 2 | 24 | |
| other | Nasopharyngitis | Infections and infestations | Cohort D: Roxadustat at 100 mg TIW | 2 | 24 |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | ||
| Total, all-cause mortality | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | ||
| Total, all-cause mortality | Cohort C: Roxadustat at 50 mg TIW | ||
| Total, all-cause mortality | Cohort D: Roxadustat at 100 mg TIW | ||
| Total, all-cause mortality | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | ||
| Total, all-cause mortality | Cohort F: Roxadustat at 70 mg BIW Then QW | ||
| Total, other adverse events | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | 15 | 24 |
| Total, other adverse events | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | 15 | 24 |
| Total, other adverse events | Cohort C: Roxadustat at 50 mg TIW | 10 | 24 |
| Total, other adverse events | Cohort D: Roxadustat at 100 mg TIW | 10 | 24 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36005278 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01244763
GET https://conductscience.org/api/trials/v1/NCT01244763/results?page=2