Trial · NCT01630889
Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
NCT01630889, Phase 2, Completed, Kyntra Bio; results first posted 2021-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease. Trials, record NCT01630889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01630889
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
- NCT number
- NCT01630889
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease, Anemia
- Interventions
- Roxadustat
- First posted
- 2012-06-28
- Last updated
- 2021-10-01
- Results first posted
- 2021-10-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hb Over Time | Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384 | Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as "over time" for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identified for this primary outcome measure. |
| Secondary | Number of Participants With Hb ≥10 g/dL | Baseline up to Week 384 | Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. |
| Secondary | Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA]) | Baseline up to Week 385 | |
| Secondary | Mean Weekly Dose of Study Drug Over Time | Baseline up to Week 384 | Weekly dose amount was the actual total dose amounts within a week, windowed by 7-day period from Day 1. The mean weekly dose is presented for selected time periods based on timepoints reported in Outcome Measures 1 and 2. |
| Secondary | Number of Participants With Dose Adjustments up to Week 52 | Baseline up to Week 52 | Dose adjustments include dose increases, dose interruptions, and dose reductions. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to Week 385 | An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hb Over Time | Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384 | Participants who received at least 1 dose of study drug. | g/dL | MEAN |
| SECONDARY | Number of Participants With Hb ≥10 g/dL | Baseline up to Week 384 | Participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA]) | Baseline up to Week 385 | Participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Weekly Dose of Study Drug Over Time | Baseline up to Week 384 | Participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | mg | MEAN |
| SECONDARY | Number of Participants With Dose Adjustments up to Week 52 | Baseline up to Week 52 | Participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to Week 385 | Participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hb Over Time | Roxadustat | Baseline | 10.05 | Standard Deviation 0.931 | g/dL |
| Change From Baseline in Hb Over Time | Roxadustat | Change at Week 8 | 1.26 | Standard Deviation 0.633 | g/dL |
| Change From Baseline in Hb Over Time | Roxadustat | Change at Week 24 | 1.58 | Standard Deviation 0.959 | g/dL |
| Change From Baseline in Hb Over Time | Roxadustat | Change at Week 48 | 1.94 | Standard Deviation 1.324 | g/dL |
| Change From Baseline in Hb Over Time | Roxadustat | Change at Week 72 | 2.54 | Standard Deviation 1.234 | g/dL |
| Change From Baseline in Hb Over Time | Roxadustat | Change at Week 96 | 1.18 | Standard Deviation 1.141 | g/dL |
| Change From Baseline in Hb Over Time | Roxadustat | Change at Week 120 | 1.61 | Standard Deviation 0.815 | g/dL |
| Change From Baseline in Hb Over Time | Roxadustat | Change at Week 144 | 1.96 | Standard Deviation 0.804 | g/dL |
| Change From Baseline in Hb Over Time | Roxadustat | Change at Week 168 | 1.40 | Standard Deviation 1.441 | g/dL |
| Change From Baseline in Hb Over Time | Roxadustat | Change at Week 192 | 1.02 | Standard Deviation 1.063 | g/dL |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roxadustat | 15 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Roxadustat | 15 | |
| Overall Study | COMPLETED | Roxadustat | 5 | |
| Overall Study | NOT COMPLETED | Roxadustat | 10 |
Source ClinicalTrials.gov
Adverse events136
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 | Anaemia | Blood and lymphatic system disorders | Roxadustat | 1 | 15 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Roxadustat | 1 | 15 | |
| other | Atrial fibrillation | Cardiac disorders | Roxadustat | 2 | 15 | |
| other | Palpitations | Cardiac disorders | Roxadustat | 1 | 15 | |
| other | Vertigo | Ear and labyrinth disorders | Roxadustat | 1 | 15 | |
| other | Hypothyroidism | Endocrine disorders | Roxadustat | 1 | 15 | |
| other | Cataract | Eye disorders | Roxadustat | 2 | 15 | |
| other | Abdominal hernia | Gastrointestinal disorders | Roxadustat | 1 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Roxadustat | 3 | 15 | |
| other | Constipation | Gastrointestinal disorders | Roxadustat | 1 | 15 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 2 | 15 |
| Total, other adverse events | Roxadustat | 14 | 15 |
| Total, serious adverse events | Roxadustat | 9 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01630889
GET https://conductscience.org/api/trials/v1/NCT01630889/results?page=2