Trial · NCT01750190
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
NCT01750190, Phase 3, Completed, Kyntra Bio; results first posted 2021-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis. Trials, record NCT01750190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01750190
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
- NCT number
- NCT01750190
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 922 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- CKD Anemia
- Interventions
- Roxadustat, Placebo
- First posted
- 2012-12-17
- Last updated
- 2021-10-01
- Results first posted
- 2021-10-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy | Baseline (Day 1, Week 0), Weeks 28 to 52 | The change in Hb from baseline to the average level during the evaluation period (defined as Week 28 until Week 52) is reported. Hb values under the influence of a rescue therapy were not censored. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug. |
| Primary | Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy | Baseline up to Week 24 | The number of participants who achieved a Hb response at 2 consecutive visits at least 5 days apart during the first 24 weeks of treatment, without rescue therapy (that is, red blood cell \[RBC\] transfusion, erythropoiesis-stimulating agent \[ESA\], or intravenous \[IV\] iron) are reported. A Hb response is defined, using central laboratory values, as the following: * Hb ≥11 g/dL and Hb increase from baseline by ≥1 g/dL in participants with baseline Hb \>8 g/dL, or * An increase in Hb by ≥2 g/dL in participants with baseline Hb ≤8.0 g/dL |
| Secondary | Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Baseline (Day 1, Week 0), Weeks 28 to 36 | For Ex-US submission only: Hb values under the influence of a rescue therapy were censored by mixed effect model of repeated measures (MMRM) for up to 6 weeks. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug. |
| Secondary | Mean Change From Baseline in Hb Averaged Over Weeks 28 to 52 Regardless of Rescue Therapy in Participants With Baseline C-Reactive Protein (CRP) >Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Weeks 28 to 52 | Hb values under the influence of a rescue therapy were not censored in the analysis. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study treatment. |
| Secondary | Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Weeks 28 to 36 | 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. |
| Secondary | Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28 | Baseline (Day 1, Week 0), Weeks 12 to 28 | Baseline LDL cholesterol was defined as the last LDL cholesterol value prior to the first dose of study drug. |
| Secondary | Rate of Change in eGFR From Baseline up to 12 Months (Linear Random Coefficient Model With Observed Data) | Baseline, Month 12 | Progression of chronic kidney disease was measured by rate of change in eGFR over time adjusted by baseline eGFR, with censoring for chronic dialysis or kidney transplant, using random slope and intercept model. Least Square Mean of change from baseline at 1 year was derived based on a random slopes and intercepts model using all available eGFR values (1 baseline and all post-treatment values up to end of treatment period + 7 days or start of dialysis) adjusted on treatment, baseline Hb, baseline eGFR, geographical region, cardiovascular events history at Baseline (yes vs. no), time (continuous value), the interaction terms of baseline eGFR by time, baseline Hb by time, and treatment by time as fixed effects, with random effects of intercept and linear slope of time. All assessments collected after the start of stable dialysis or kidney transplant were excluded from the analysis. |
| Secondary | Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment | Baseline up to Week 52 | Participants with any use of blood/RBC transfusion were reported. |
| Secondary | Number (%) of Participants Who Received Rescue Therapy in the First 24 Weeks and in the First 52 Weeks of Treatment | Baseline (Day 1, Week 0) up to Week 24 and up to Week 52 | Rescue therapy included any use of RBC transfusion, ESA, or IV iron. |
| Secondary | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28 | Baseline (Day 1, Week 0), Weeks 12 to 28 | The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). A higher score indicates a general improvement of life quality or well-being. Baseline score was defined as the last physical functioning value or vitality value, as applicable, prior to the first dose of study drug. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy | Baseline (Day 1, Week 0), Weeks 28 to 52 | ITT Population included all randomized/enrolled participants. | g/dL | MEAN |
| PRIMARY | Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy | Baseline up to Week 24 | FAS Population included of all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Baseline (Day 1, Week 0), Weeks 28 to 36 | 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. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | g/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Hb Averaged Over Weeks 28 to 52 Regardless of Rescue Therapy in Participants With Baseline C-Reactive Protein (CRP) >Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Weeks 28 to 52 | 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. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | g/dL | MEAN |
| SECONDARY | Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Weeks 28 to 36 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28 | Baseline (Day 1, Week 0), Weeks 12 to 28 | 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. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | mg/dL | MEAN |
| SECONDARY | Rate of Change in eGFR From Baseline up to 12 Months (Linear Random Coefficient Model With Observed Data) | Baseline, Month 12 | 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. | ml/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment | Baseline up to Week 52 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants Who Received Rescue Therapy in the First 24 Weeks and in the First 52 Weeks of Treatment | Baseline (Day 1, Week 0) up to Week 24 and up to Week 52 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28 | Baseline (Day 1, Week 0), Weeks 12 to 28 | 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. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. | scores on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy | Roxadustat | Baseline | 9.10 | Standard Deviation 0.75 | g/dL |
| United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy | Placebo | Baseline | 9.09 | Standard Deviation 0.69 | g/dL |
| United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy | Roxadustat | Change at Weeks 28 to 52 | 2.00 | Standard Deviation 0.952 | g/dL |
| United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy | Placebo | Change at Weeks 28 to 52 | 0.16 | Standard Deviation 0.895 | g/dL |
| Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy | Roxadustat | 523 | Participants | ||
| Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy | Placebo | 20 | Participants | ||
| Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Roxadustat | Baseline | 9.09 | Standard Deviation 0.749 | g/dL |
| Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Placebo | Baseline | 9.09 | Standard Deviation 0.694 | g/dL |
| Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Roxadustat | Change at Weeks 28 to 36 | 2.02 | Standard Deviation 1.067 | g/dL |
| Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Placebo | Change at Weeks 28 to 36 | 0.20 | Standard Deviation 0.994 | g/dL |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roxadustat | 616 | |
| Overall Study | STARTED | Placebo | 306 | |
| Overall Study | Safety Population | Roxadustat | 611 | |
| Overall Study | Safety Population | Placebo | 305 | |
| Overall Study | Full Analysis Set (FAS) | Roxadustat | 608 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 305 | |
| Overall Study | COMPLETED | Roxadustat | 349 | |
| Overall Study | COMPLETED | Placebo | 98 | |
| Overall Study | NOT COMPLETED | Roxadustat | 267 | |
| Overall Study | NOT COMPLETED | Placebo | 208 |
Source ClinicalTrials.gov
Adverse events800
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 | Anemia | Blood and lymphatic system disorders | Roxadustat | 12 | 611 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 39 | 305 | |
| other | Constipation | Gastrointestinal disorders | Roxadustat | 103 | 611 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 34 | 305 | |
| other | Nausea | Gastrointestinal disorders | Roxadustat | 85 | 611 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 29 | 305 | |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat | 77 | 611 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 31 | 305 | |
| other | Vomiting | Gastrointestinal disorders | Roxadustat | 52 | 611 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 20 | 305 |
1 to 10 of 800Source ClinicalTrials.gov
See all 800 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 38 | 611 |
| Total, all-cause mortality | Placebo | 11 | 305 |
| Total, other adverse events | Roxadustat | 468 | 611 |
| Total, other adverse events | Placebo | 216 | 305 |
| Total, serious adverse events | Roxadustat | 321 | 611 |
| Total, serious adverse events | Placebo | 120 | 305 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Roxadustat vs Placebo: Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment | Trial comparisons |
| Roxadustat vs Placebo: Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Trial comparisons |
| Roxadustat vs Placebo: Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy | Trial comparisons |
| Roxadustat vs Placebo: Number (%) of Participants Who Experienced Exacerbation of Hypertension | Trial comparisons |
| Roxadustat vs Placebo: deaths from any cause | Trial comparisons |
| Roxadustat vs Placebo: serious adverse events | Trial comparisons |
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/NCT01750190
GET https://conductscience.org/api/trials/v1/NCT01750190/results?page=2