Trial · NCT00761657
Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
NCT00761657, Phase 2, Completed, Kyntra Bio; results first posted 2021-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis. Trials, record NCT00761657. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00761657
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
- NCT number
- NCT00761657
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 117 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- Chronic Kidney Disease, Anemia
- Interventions
- Roxadustat, Placebo
- First posted
- 2008-09-29
- Last updated
- 2021-11-19
- Results first posted
- 2021-11-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Baseline up to Week 16 (End of Study (EoS]) | 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 defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or definite relationship to study drug. 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. |
| Primary | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing) | Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline was defined as the mean of last 3 available values prior to the first dose. |
| Primary | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline, Week 8 (2 Weeks of Follow Up) | Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline is defined as the mean of last 3 available values prior to the first dose. |
| Secondary | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up) | Hb response defined as an increase in Hb from baseline by ≥1.0 g/dL (not due to red blood cell transfusion or IV iron supplementation during treatment). The baseline for Hb was defined as the mean of the last 3 available Hb values obtained prior to the first dose. |
| Secondary | Plasma Roxadustat Concentration (Part 2) | Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups) | |
| Secondary | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing) | Baseline is defined as the last value obtained prior to the first dose. |
| Secondary | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Baseline, 4, 8, 12, and 24 hours on Day 1 | Baseline is defined as the last value obtained prior to the first dose. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Baseline up to Week 16 (End of Study (EoS]) | Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing) | Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL and were in study treatment for at least 2.5 weeks with corresponding Hb values. Last-observation-carried-forward (LOCF) method was used to impute missing values. | g/dL | MEAN |
| PRIMARY | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline, Week 8 (2 Weeks of Follow Up) | Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL and were in study treatment for at least 2.5 weeks with corresponding Hb values. LOCF method was used to impute missing values. | g/dL | MEAN |
| SECONDARY | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up) | Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL) and were in study treatment for at least 2.5 weeks with corresponding Hb values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Roxadustat Concentration (Part 2) | Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups) | Part 2 PK Population: Participants who received roxadustat and had sufficient plasma data to allow calculation of PK parameters. Participants in the roxadustat groups were evaluated. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. | nanograms (ng)/milliliter (mL) | MEAN |
| SECONDARY | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing) | Part 1 Safety Population: Participants who received at least 1 dose of study drug. Participants with missing erythropoietin values at any timepoint were excluded from analysis. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | milli-international units (mIU)/mL | MEAN |
| SECONDARY | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Baseline, 4, 8, 12, and 24 hours on Day 1 | Part 2 PK Population: Participants who received roxadustat and had sufficient plasma data to allow calculation of PK parameters. Participants with missing erythropoietin values at any timepoint were excluded from analysis. | mIU/mL | MEAN |
Source ClinicalTrials.gov
Results by group213
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Roxadustat 0.7 mg/kg BIW | Any TEAEs | 3 | Participants | |
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Roxadustat 0.7 mg/kg TIW | Any TEAEs | 9 | Participants | |
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Roxadustat 1.0 mg/kg BIW | Any TEAEs | 7 | Participants | |
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Roxadustat 1.0 mg/kg TIW | Any TEAEs | 5 | Participants | |
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Roxadustat 1.5 mg/kg BIW | Any TEAEs | 9 | Participants | |
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Roxadustat 1.5 mg/kg TIW | Any TEAEs | 7 | Participants | |
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Roxadustat 2.0 mg/kg BIW | Any TEAEs | 7 | Participants | |
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Roxadustat 2.0 mg/kg TIW | Any TEAEs | 5 | Participants | |
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Placebo | Any TEAEs | 13 | Participants | |
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Roxadustat 0.7 mg/kg BIW | Serious TEAEs | 0 | Participants |
1 to 10 of 213Source ClinicalTrials.gov
See all 213 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (up to Day 57) | STARTED | Roxadustat 0.7 Milligrams/Kilograms (mg/kg) BIW | 0 | |
| Part 1 (up to Day 57) | STARTED | Roxadustat 0.7 mg/kg TIW | 0 | |
| Part 1 (up to Day 57) | STARTED | Roxadustat 1.0 mg/kg BIW | 12 | |
| Part 1 (up to Day 57) | STARTED | Roxadustat 1.0 mg/kg TIW | 10 | |
| Part 1 (up to Day 57) | STARTED | Roxadustat 1.5 mg/kg BIW | 0 | |
| Part 1 (up to Day 57) | STARTED | Roxadustat 1.5 mg/kg TIW | 0 | |
| Part 1 (up to Day 57) | STARTED | Roxadustat 2.0 mg/kg BIW | 1 | |
| Part 1 (up to Day 57) | STARTED | Roxadustat 2.0 mg/kg TIW | 2 | |
| Part 1 (up to Day 57) | STARTED | Placebo | 10 | |
| Part 1 (up to Day 57) | Safety Population | Roxadustat 0.7 Milligrams/Kilograms (mg/kg) BIW | 0 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events882
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 | Roxadustat 0.7 mg/kg BIW | 0 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat 0.7 mg/kg TIW | 3 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat 1.0 mg/kg BIW | 2 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat 1.0 mg/kg TIW | 1 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat 1.5 mg/kg BIW | 1 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat 1.5 mg/kg TIW | 0 | 11 | |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat 2.0 mg/kg BIW | 1 | 11 | |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat 2.0 mg/kg TIW | 0 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 28 | |
| other | Constipation | Gastrointestinal disorders | Roxadustat 0.7 mg/kg BIW | 0 | 10 |
1 to 10 of 882Source ClinicalTrials.gov
See all 882 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat 0.7 mg/kg BIW | ||
| Total, all-cause mortality | Roxadustat 0.7 mg/kg TIW | ||
| Total, all-cause mortality | Roxadustat 1.0 mg/kg BIW | ||
| Total, all-cause mortality | Roxadustat 1.0 mg/kg TIW | ||
| Total, all-cause mortality | Roxadustat 1.5 mg/kg BIW | ||
| Total, all-cause mortality | Roxadustat 1.5 mg/kg TIW | ||
| Total, all-cause mortality | Roxadustat 2.0 mg/kg BIW | ||
| Total, all-cause mortality | Roxadustat 2.0 mg/kg TIW | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Roxadustat 0.7 mg/kg BIW | 3 | 10 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
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 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/NCT00761657
GET https://conductscience.org/api/trials/v1/NCT00761657/results?page=2