Trial · NCT01414075
Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
NCT01414075, Phase 2, Completed, Kyntra Bio; results first posted 2021-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment. Trials, record NCT01414075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01414075
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
- NCT number
- NCT01414075
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- Dialysis, Anemia
- Interventions
- Roxadustat, Oral Iron, IV Iron
- First posted
- 2011-08-11
- Last updated
- 2021-10-01
- Results first posted
- 2021-10-01
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation. |
| Secondary | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Baseline, Weeks 2-5, 6-9, and 10-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL | Week 3 to 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL | Week 3 to 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Weeks 5, 9, and 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | Weeks 3-13 | |
| Secondary | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: \<1 g/dL, ≥1 g/dL, 1 to \<2 g/dL, 2 to \<3 g/dL, \>3 to \<4 g/dL, ≥4 g/dL. |
| Secondary | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Secondary | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Weeks 5 and 9 | Number of participants requiring dose increase due to any reasons is reported. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. | grams/deciliter (g/dL) | MEAN |
| SECONDARY | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Baseline, Weeks 2-5, 6-9, and 10-13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | g/dL | MEAN |
| SECONDARY | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL | Week 3 to 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL | Week 3 to 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Weeks 5, 9, and 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | Weeks 3-13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values. | weeks | MEDIAN |
| SECONDARY | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. LOCF method was used to impute missing values. | mg/kg | MEAN |
| SECONDARY | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Weeks 5 and 9 | Safety population included all participants who received any dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group258
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Change From Baseline in Hb During Weeks 3-13 | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Baseline | 8.1 | Standard Error 0.2 | grams/deciliter (g/dL) |
| Maximum Change From Baseline in Hb During Weeks 3-13 | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Baseline | 8.5 | Standard Error 0.3 | grams/deciliter (g/dL) |
| Maximum Change From Baseline in Hb During Weeks 3-13 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Baseline | 8.4 | Standard Error 0.3 | grams/deciliter (g/dL) |
| Maximum Change From Baseline in Hb During Weeks 3-13 | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Baseline | 8.7 | Standard Error 0.2 | grams/deciliter (g/dL) |
| Maximum Change From Baseline in Hb During Weeks 3-13 | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change at Weeks 3-13 | 2.8 | Standard Error 0.2 | grams/deciliter (g/dL) |
| Maximum Change From Baseline in Hb During Weeks 3-13 | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change at Weeks 3-13 | 3.5 | Standard Error 0.5 | grams/deciliter (g/dL) |
| Maximum Change From Baseline in Hb During Weeks 3-13 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change at Weeks 3-13 | 3.5 | Standard Error 0.4 | grams/deciliter (g/dL) |
| Maximum Change From Baseline in Hb During Weeks 3-13 | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change at Weeks 3-13 | 3.3 | Standard Error 0.2 | grams/deciliter (g/dL) |
| Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Baseline | 8.1 | Standard Error 0.2 | g/dL |
| Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Baseline | 8.5 | Standard Error 0.3 | g/dL |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A + E (Participants on HD): Roxadustat Only, No Iron | 24 | |
| Overall Study | STARTED | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 12 | |
| Overall Study | STARTED | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 12 | |
| Overall Study | STARTED | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 12 | |
| Overall Study | Efficacy Evaluable (EE) Population | Arm A + E (Participants on HD): Roxadustat Only, No Iron | 23 | |
| Overall Study | Efficacy Evaluable (EE) Population | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 12 | |
| Overall Study | Efficacy Evaluable (EE) Population | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 10 | |
| Overall Study | Efficacy Evaluable (EE) Population | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 10 | |
| Overall Study | COMPLETED | Arm A + E (Participants on HD): Roxadustat Only, No Iron | 21 | |
| Overall Study | COMPLETED | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 12 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events44
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 | Transferrin saturation decreased | Investigations | Arm A + E (Participants on HD): Roxadustat Only, No Iron | 3 | 24 | |
| other | Transferrin saturation decreased | Investigations | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 1 | 12 | |
| other | Transferrin saturation decreased | Investigations | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 0 | 12 | |
| other | Transferrin saturation decreased | Investigations | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 | 12 | |
| other | Hypertension | Vascular disorders | Arm A + E (Participants on HD): Roxadustat Only, No Iron | 1 | 24 | |
| other | Hypertension | Vascular disorders | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 3 | 12 | |
| other | Hypertension | Vascular disorders | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 0 | 12 | |
| other | Hypertension | Vascular disorders | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 2 | 12 | |
| other | Phlebitis | Vascular disorders | Arm A + E (Participants on HD): Roxadustat Only, No Iron | 2 | 24 | |
| other | Phlebitis | Vascular disorders | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 1 | 12 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A + E (Participants on HD): Roxadustat Only, No Iron | ||
| Total, all-cause mortality | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | ||
| Total, all-cause mortality | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | ||
| Total, all-cause mortality | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | ||
| Total, other adverse events | Arm A + E (Participants on HD): Roxadustat Only, No Iron | 6 | 24 |
| Total, other adverse events | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 4 | 12 |
| Total, other adverse events | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 0 | 12 |
| Total, other adverse events | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 2 | 12 |
| Total, serious adverse events | Arm A + E (Participants on HD): Roxadustat Only, No Iron | 3 | 24 |
| Total, serious adverse events | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 1 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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Read this trial from software.
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