Trial · NCT01147666
Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis
NCT01147666, Phase 2, Completed, Kyntra Bio; results first posted 2022-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis. Trials, record NCT01147666. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01147666
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis
- NCT number
- NCT01147666
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 161 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- End Stage Renal Disease, Anemia
- Interventions
- Roxadustat, Epoetin Alfa, Placebo
- First posted
- 2010-06-22
- Last updated
- 2022-01-11
- Results first posted
- 2022-01-11
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only | Week 7 | Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values. |
| Primary | Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks | Week 7 | Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. |
| Primary | Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks | Weeks 17, 18, 19, and 20 | The average of the mean Hb values that were above 11 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values. |
| Secondary | Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks) | Weeks 17, 18, 19, and 20 | The average of the mean Hb values that were within 11-13 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values. |
| Secondary | Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks) | Weeks 17, 18, 19, and 20 | The average of the mean Hb values that were within 10-13 g/dL at Weeks 17, 18, 19, and 20 are presented. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. LOCF method was used to impute missing values. |
| Secondary | Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks | Baseline, Week 7 | Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. |
| Secondary | Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks | Baseline, Weeks 8, 10, 12, 14, 17, 19, and 20 | Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. |
| Secondary | Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only | Baseline up to Week 6 | Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. |
| Secondary | Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks | Baseline up to Week 19 | Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. |
| Secondary | Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks | Week 7 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only | Week 7 | EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (erythropoiesis-stimulating agent \[ESA\], IV Iron or red blood cell \[RBC\] transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. Here, 'Overall number of participants analyzed' signifies normoresponder participants who were treated for 6 weeks only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks | Week 7 | EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks | Weeks 17, 18, 19, and 20 | EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks) | Weeks 17, 18, 19, and 20 | EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks) | Weeks 17, 18, 19, and 20 | EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks | Baseline, Week 7 | EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks | Baseline, Weeks 8, 10, 12, 14, 17, 19, and 20 | EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy. | g/dL | MEAN |
| SECONDARY | Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only | Baseline up to Week 6 | Safety population included all participants who were randomized and received at least one dose of study medication. Here, 'Overall number of participants analyzed' signifies participants who were treated for 6 weeks only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks | Baseline up to Week 19 | Safety population included all participants who were randomized and received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks | Week 7 | EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group327
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 Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only | Cohort A-1 (Roxadustat 1.0 mg/kg TIW) | 4 | Participants | ||
| Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only | Cohort A-2 (Roxadustat 1.5 mg/kg TIW) | 8 | Participants | ||
| Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only | Cohort A-3 (Roxadustat 2.0 mg/kg TIW) | 7 | Participants | ||
| Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only | Cohort A-4 (Roxadustat 1.8 mg/kg TIW) | 4 | Participants | ||
| Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only | Cohort A (Epoetin Alfa) | 3 | Participants | ||
| Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks | Cohort B-1 (Roxadustat 1.5 mg/kg TIW) | 0 | Participants | ||
| Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks | Cohort B-2 (Roxadustat 2.0 mg/kg TIW) | 1 | Participants | ||
| Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks | Cohort B (Epoetin Alfa) | 2 | Participants | ||
| Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks | Cohort B (Placebo) | 0 | Participants | ||
| Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks | Cohort A-4 (Roxadustat 1.8 mg/kg TIW) | 4 | Participants |
1 to 10 of 327Source ClinicalTrials.gov
See all 327 results by groupParticipant flow150
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-1 (Roxadustat 1.0 mg/kg TIW) | 12 | |
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-2 (Roxadustat 1.5 mg/kg TIW) | 12 | |
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-3 (Roxadustat 2.0 mg/kg TIW) | 12 | |
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-4 (Roxadustat 1.8 mg/kg TIW) | 12 | |
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-5 (Roxadustat 1.8 mg/kg TIW) | 12 | |
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-6 (Roxadustat 1.3 mg/kg TIW) | 12 | |
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg) | 12 | |
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg) | 12 | |
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-9 (Roxadustat 2.0 mg/kg) | 2 | |
| Dosing Period 1: 6-Week Treatment | STARTED | Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg) | 10 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 participant flowAdverse events975
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 | Diarrhoea | Gastrointestinal disorders | Cohort A-1 (Roxadustat 1.0 mg/kg TIW) | 1 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A-2 (Roxadustat 1.5 mg/kg TIW) | 1 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A-3 (Roxadustat 2.0 mg/kg TIW) | 0 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A-4 (Roxadustat 1.8 mg/kg TIW) | 2 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A-5 (Roxadustat 1.8 mg/kg TIW) | 2 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A-6 (Roxadustat 1.3 mg/kg TIW) | 2 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg) | 0 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg) | 0 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A-9 (Roxadustat 2.0 mg/kg) | 0 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg) | 0 | 10 |
1 to 10 of 975Source ClinicalTrials.gov
See all 975 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A-1 (Roxadustat 1.0 mg/kg TIW) | ||
| Total, all-cause mortality | Cohort A-2 (Roxadustat 1.5 mg/kg TIW) | ||
| Total, all-cause mortality | Cohort A-3 (Roxadustat 2.0 mg/kg TIW) | ||
| Total, all-cause mortality | Cohort A-4 (Roxadustat 1.8 mg/kg TIW) | ||
| Total, all-cause mortality | Cohort A-5 (Roxadustat 1.8 mg/kg TIW) | ||
| Total, all-cause mortality | Cohort A-6 (Roxadustat 1.3 mg/kg TIW) | ||
| Total, all-cause mortality | Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg) | ||
| Total, all-cause mortality | Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg) | ||
| Total, all-cause mortality | Cohort A-9 (Roxadustat 2.0 mg/kg) | ||
| Total, all-cause mortality | Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg) |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 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/NCT01147666
GET https://conductscience.org/api/trials/v1/NCT01147666/results?page=2