A Phase 3 interventional study of Roxadustat and Placebo in Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts) and Anemia, sponsored by FibroGen. Terminated at 124 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by FibroGen · Phase 3, Interventional, and Treatment
Among 43 studies testing roxadustat in Anemia — 2 open to participants now, 4 under way, 3 of them phase 3. roxadustat · Anemia.
Among the 43 studies testing roxadustat in Anemia, this one is the 17th largest by enrollment, is one of 2 that started in 2018, is one of 25 in phase 3, and was the 25th registered.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
Browse Anemia studies →2 of the 43 studies testing roxadustat in Anemia are open now. Recruiting first, the newest first:
Kyntra Bio
Ages 18+
Tianjin Medical University General Hospital
Ages 18–80
roxadustat: first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 9 · Phase 3 26 · Phase 4 7
First in 2006; this study’s year is marked. 2 started in 2018.
This study's enrollment of 184 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Median enrollment 154 across the 43 interventional studies. Of the 36 that completed or were terminated, 18 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
35 of 43 have an industry lead sponsor. The 10 most frequent:
This study is registered under FibroGen, one of the names counted as Kyntra Bio. Under that name alone:
FibroGen is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
21 studies in Anemia by Kyntra Bio: 1 open now, 1 under way, 1 of them phase 3. Of 19 finished, 12 (63%) have results posted.
Among the 21 studies in Anemia by Kyntra Bio, this one is the 9th largest by enrollment, is one of 2 that started in 2018, is one of 11 in phase 3, and was the 13th registered.
Kyntra Bio’s Anemia studies by the year they started, since 2006.
1 of the studies testing roxadustat in Anemia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05970172Phase 3Astellas Pharma Global Development, Inc.A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease | 2027-10-30 |
Add it to your calendar (.ics) → With an account.
Among the 43 studies testing roxadustat in Anemia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Kyntra Bio’s 21 in Anemia:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.
This study includes an Open-Label Lead in, a Double-Blind component, and an Open-Label High Erythropoietin component. There is a screening period of up to 42 days followed by a treatment period of 52 weeks and a 4-week end of treatment assessment.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open-label, lead-in: Participants will receive sequential escalating roxadustat doses (1.5 milligrams/kilograms \[mg/kg\], 2.0 mg/kg and 2.5 mg/kg), three times a week (TIW) based upon their actual weight at the randomization visit to identify the starting dose for double-blind period. Double-blind: Participants will receive roxadustat 2.5 mg/kg TIW based upon their body weight for a duration of 52 weeks. Open-label: Participants with high serum erythropoietin levels (\>400 milli-international units \[mIU\]/milliliter \[mL\] mIU/mL) will receive roxadustat 2.5 mg/kg TIW based upon their body weight for a duration of 52 weeks.
Drug: Roxadustat
Double-blind: Participants will receive placebo matching to roxadustat for a duration of 52 weeks.
Drug: Placebo
Oral tablets
Also known as: FG-4592, ASP1517, AZD9941
Oral tablets
OL and OL High-EPO Components: Number of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) ≥8 Weeks (≥56 Consecutive Days) Since First Dose in the First 28 Weeks of Treatment
The RBC TI was defined as the absence of any intravenous (IV) RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥8 weeks (≥56 consecutive days) since first dose in the first 28 weeks of treatment.
Time frame: 28 weeks
DB Component: Number of Participants Who Achieved RBC TI ≥56 Consecutive Days Since First Dose in the First 28 Weeks of Treatment
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥56 consecutive days since first dose in the first 28 weeks of treatment.
Time frame: 28 weeks
OL and OL High-EPO Components: Number of Participants Who Achieved TI ≥50% Reduction From Baseline in Number of Packs of Red Blood Cells (pRBC) Transfusions Over 8 Weeks
Number of pRBC transfusions at baseline was defined as pRBC transfusions requirement during 8-week period prior to the start of first study medication. Responders were defined as participants with at least a 50% reduction in the number of pRBC transfusions over any 8-week (56 consecutive days) period during the study as compared with the baseline.
Time frame: Baseline up to Week 8
DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Since First Dose in 52 Weeks of Treatment
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥56 consecutive days since first dose in the 52 weeks of treatment.
Time frame: 52 weeks
DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Anytime During the Study
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days anytime during the study (up to Week 56).
Time frame: Baseline up to Week 56
DB Component: Number of Participants Who Achieved ≥50% Reduction From Baseline in Number of pRBC Transfusions Over 8 Weeks
Baseline number of transfusions (pRBC/8-weeks) = total number of packs of rRBCs within 16 weeks prior to first dose/2. A pRBC transfusion reduction responder was defined as a participant who achieved ≥50% reduction in number of pRBC transfusions over 8 weeks compared to their baseline for any 8 week period in the duration begining with the first dose date (Day 1) and ending with the end of study or treatment discontinuation due to adverse event (AE)/serious adverse event (SAE) or death, whichever came earlier.
Time frame: Baseline up to Week 8
DB Component: Cumulative Number of Participant Exposure Weeks (PEW) of TI Over the First 28 Weeks of Treatment
The PEW of TI periods over the first 28 weeks was added up to a cumulative number of weeks. For a participant with at least 1 TI response period over the first 28 weeks, the last TI response period was ended with the date of a subsequent RBC transfusion, visit date at Week 28, date of the end of study or treatment discontinuation due to AE/SAE or death, whichever came earlier. For a participant with no TI response period over the first 28 weeks, the cumulative number of PEW was set to zero.
Time frame: 28 weeks
DB Component: Change From Baseline in Number of pRBC Packs Transfused Over the First 28 Weeks of Treatment
Number of pRBC transfusions at baseline was defined as pRBC transfusions requirement during 8-week period prior to the start of first study medication.
Time frame: Baseline, Week 28
DB Component: Number of Participants Who Achieved TI ≥20 Consecutive Weeks During the Study
≥20 consecutive weeks TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 140 days anytime during the study (up to 56 weeks). TI was estimated between the first dose date (Day 1) and the end of study (Week 56) or treatment discontinuation due to AE/SAE or death, whichever came earlier.
Time frame: Baseline up to Week 56
DB Component: Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System-Short Form (PROMIS-SF) v2.0 Physical Function (PF) 10b Score at Week 9
The PROMIS physical function item measures self-reported, current capability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. The PF 10-item short form which contains 10 questions was used in this study, and each item was scored on a 5-point rating scale (1 \[unable to do\] to 5 \[without any difficulty\]), with higher scores indicating better functioning. Total raw score was the sum of the response to each question, with the lowest possible raw score 10 (poor physical function) and the highest possible raw score 50 (better physical function). Raw scores converted to T-scores (as detailed in the T-score conversion table for PROMIS-SF v2.0 Physical Function 10b) with a mean of 50 and a standard deviation (SD) of 10. T-scores ranged from minimum 13.8 to maximum 61.3 possible scores with higher scores indicating better physical functioning.
Time frame: Baseline, Week 9
DB Component: Mean Change From Baseline in the PROMIS-SF v1.0 Fatigue 13a Score at Week 9
Fatigue was measured using the 13-item fatigue scale of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, each item was scored on a 5-point rating scale ranging from 1 "not at all" to 5 "very much", with lower scores indicating better functioning. Total raw score was the sum of the response to each question, with the lowest possible raw score 13 (lowest level of fatigue) and the highest possible raw score 65 (highest level of fatigue), with lower scores indicating better functioning. Raw scores converted to T-scores (as detailed in the T-score conversion table for PROMIS-SF v1.0 Fatigue 13a) with a mean of 50 and a SD of 10. T-scores ranged from minimum 30.3 to maximum 83.5 possible scores with lower scores indicating better functioning.
Time frame: Baseline, Week 9
DB Component: Mean Change From Baseline in the European Quality of Life Five Dimensional Five Level Health Questionnaire (EQ-5D-5L) Visual Analogue Scale Score at Week 9
The EQ-5D questionnaire is designed for self-completion by participants. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problem, moderate problems, severe problems, and unable to/extreme problems. The questionnaire also included a visual analogue scale, where the participant was asked to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state and 100 being the best imaginable health.
Time frame: Baseline, Week 9
The study included 3 components: Open-label (OL) Lead-in, Double-blind (DB), and OL High-erythropoietin (High-EPO) component.
| Milestone | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 0 | 0 | 0 |
| Received at least 1 dose of study drug | 8 | 8 | 8 | 0 | 0 | 0 |
| Completed | 6 | 6 | 6 | 0 | 0 | 0 |
| Not completed | 2 | 2 | 2 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 2 | 0 | 0 | 0 |
| Withdrew: Death | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 20 | 0 | 0 |
| Received at least 1 dose of study drug | 0 | 0 | 0 | 20 | 0 | 0 |
| Completed | 0 | 0 | 0 | 10 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 10 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 6 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 3 | 0 | 0 |
| Milestone | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 82 | 58 |
| Received at least 1 dose of study drug | 0 | 0 | 0 | 0 | 82 | 58 |
| Completed | 0 | 0 | 0 | 0 | 38 | 37 |
| Not completed | 0 | 0 | 0 | 0 | 44 | 21 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 22 | 8 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 3 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 2 | 1 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 7 | 4 |
| Withdrew: Other than specified | 0 | 0 | 0 | 0 | 8 | 6 |
The RBC TI was defined as the absence of any intravenous (IV) RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥8 weeks (≥56 consecutive days) since first dose in the first 28 weeks of treatment.
| Participants | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg |
|---|---|---|---|---|
| OL and OL High-EPO Components: Number of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) ≥8 Weeks (≥56 Consecutive Days) Since First Dose in the First 28 Weeks of Treatment | 3 | 1 | 5 | 3 |
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥56 consecutive days since first dose in the first 28 weeks of treatment.
| Participants | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Number of Participants Who Achieved RBC TI ≥56 Consecutive Days Since First Dose in the First 28 Weeks of Treatment | 38 | 19 |
Number of pRBC transfusions at baseline was defined as pRBC transfusions requirement during 8-week period prior to the start of first study medication. Responders were defined as participants with at least a 50% reduction in the number of pRBC transfusions over any 8-week (56 consecutive days) period during the study as compared with the baseline.
| Participants | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg |
|---|---|---|---|---|
| OL and OL High-EPO Components: Number of Participants Who Achieved TI ≥50% Reduction From Baseline in Number of Packs of Red Blood Cells (pRBC) Transfusions Over 8 Weeks | 5 | 3 | 7 | 8 |
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥56 consecutive days since first dose in the 52 weeks of treatment.
| Participants | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Since First Dose in 52 Weeks of Treatment | 44 | 23 |
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days anytime during the study (up to Week 56).
| Participants | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Anytime During the Study | 52 | 29 |
Baseline number of transfusions (pRBC/8-weeks) = total number of packs of rRBCs within 16 weeks prior to first dose/2. A pRBC transfusion reduction responder was defined as a participant who achieved ≥50% reduction in number of pRBC transfusions over 8 weeks compared to their baseline for any 8 week period in the duration begining with the first dose date (Day 1) and ending with the end of study or treatment discontinuation due to adverse event (AE)/serious adverse event (SAE) or death, whichever came earlier.
| Participants | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Number of Participants Who Achieved ≥50% Reduction From Baseline in Number of pRBC Transfusions Over 8 Weeks | 59 | 37 |
The PEW of TI periods over the first 28 weeks was added up to a cumulative number of weeks. For a participant with at least 1 TI response period over the first 28 weeks, the last TI response period was ended with the date of a subsequent RBC transfusion, visit date at Week 28, date of the end of study or treatment discontinuation due to AE/SAE or death, whichever came earlier. For a participant with no TI response period over the first 28 weeks, the cumulative number of PEW was set to zero.
| weeks | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Cumulative Number of Participant Exposure Weeks (PEW) of TI Over the First 28 Weeks of Treatment | 9.60 ± 11.537 | 7.60 ± 11.557 |
Number of pRBC transfusions at baseline was defined as pRBC transfusions requirement during 8-week period prior to the start of first study medication.
| pRBC packs | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Change From Baseline in Number of pRBC Packs Transfused Over the First 28 Weeks of Treatment | -0.13 ± 2.314 | 0.44 ± 1.833 |
≥20 consecutive weeks TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 140 days anytime during the study (up to 56 weeks). TI was estimated between the first dose date (Day 1) and the end of study (Week 56) or treatment discontinuation due to AE/SAE or death, whichever came earlier.
| Participants | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Number of Participants Who Achieved TI ≥20 Consecutive Weeks During the Study | 23 | 15 |
The PROMIS physical function item measures self-reported, current capability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. The PF 10-item short form which contains 10 questions was used in this study, and each item was scored on a 5-point rating scale (1 \[unable to do\] to 5 \[without any difficulty\]), with higher scores indicating better functioning. Total raw score was the sum of the response to each question, with the lowest possible raw score 10 (poor physical function) and the highest possible raw score 50 (better physical function). Raw scores converted to T-scores (as detailed in the T-score conversion table for PROMIS-SF v2.0 Physical Function 10b) with a mean of 50 and a standard deviation (SD) of 10. T-scores ranged from minimum 13.8 to maximum 61.3 possible scores with higher scores indicating better physical functioning.
| T-score | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System-Short Form (PROMIS-SF) v2.0 Physical Function (PF) 10b Score at Week 9 | -1.9 ± 7.29 | -0.4 ± 6.77 |
Fatigue was measured using the 13-item fatigue scale of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, each item was scored on a 5-point rating scale ranging from 1 "not at all" to 5 "very much", with lower scores indicating better functioning. Total raw score was the sum of the response to each question, with the lowest possible raw score 13 (lowest level of fatigue) and the highest possible raw score 65 (highest level of fatigue), with lower scores indicating better functioning. Raw scores converted to T-scores (as detailed in the T-score conversion table for PROMIS-SF v1.0 Fatigue 13a) with a mean of 50 and a SD of 10. T-scores ranged from minimum 30.3 to maximum 83.5 possible scores with lower scores indicating better functioning.
| T-score | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Mean Change From Baseline in the PROMIS-SF v1.0 Fatigue 13a Score at Week 9 | 1.9 ± 7.61 | -0.6 ± 7.36 |
The EQ-5D questionnaire is designed for self-completion by participants. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problem, moderate problems, severe problems, and unable to/extreme problems. The questionnaire also included a visual analogue scale, where the participant was asked to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state and 100 being the best imaginable health.
| units on a scale | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|
| DB Component: Mean Change From Baseline in the European Quality of Life Five Dimensional Five Level Health Questionnaire (EQ-5D-5L) Visual Analogue Scale Score at Week 9 | -1.7 ± 20.31 | 1.6 ± 16.18 |
Collected over Baseline up to Week 56. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OL Component (Cohort 1): Roxadustat 1.5 mg/kg | 1/8 (12.5%) | 4/8 (50%) | 7/8 (87.5%) |
| OL Component (Cohort 2): Roxadustat 2.0 mg/kg | 0/8 (0%) | 3/8 (37.5%) | 8/8 (100%) |
| OL Component (Cohort 3): Roxadustat 2.5 mg/kg | 0/8 (0%) | 1/8 (12.5%) | 6/8 (75%) |
| OL High-EPO Component: Roxadustat 2.5 mg/kg | 3/20 (15%) | 6/20 (30%) | 15/20 (75%) |
| DB Component: Roxadustat | 7/82 (8.5%) | 22/82 (26.8%) | 68/82 (82.9%) |
| DB Component: Placebo | 4/58 (6.9%) | 10/58 (17.2%) | 46/58 (79.3%) |
| Event | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/8 | 0/8 | 0/8 | 0/20 | 2/82 | 1/58 |
| Acute myocardial infarctionCardiac disorders | 1/8 | 0/8 | 0/8 | 0/20 | 2/82 | 0/58 |
| Cardiac failureCardiac disorders | 1/8 | 0/8 | 0/8 | 0/20 | 1/82 | 0/58 |
| Inguinal herniaGastrointestinal disorders | 1/8 | 0/8 | 0/8 | 0/20 | 0/82 | 0/58 |
| General physical health deteriorationGeneral disorders | 1/8 | 0/8 | 0/8 | 0/20 | 0/82 | 0/58 |
| Portal hypertensionHepatobiliary disorders | 0/8 | 0/8 | 1/8 | 0/20 | 0/82 | 0/58 |
| Campylobacter gastroenteritisInfections and infestations | 0/8 | 1/8 | 0/8 | 0/20 | 0/82 | 0/58 |
| InfluenzaInfections and infestations | 0/8 | 0/8 | 1/8 | 0/20 | 0/82 | 0/58 |
| Urinary tract infectionInfections and infestations | 0/8 | 1/8 | 0/8 | 0/20 | 0/82 | 0/58 |
| SyncopeNervous system disorders | 0/8 | 1/8 | 0/8 | 0/20 | 0/82 | 0/58 |
| Event | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg | DB Component: Roxadustat | DB Component: Placebo |
|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 2/8 | 3/8 | 1/8 | 2/20 | 6/82 | 9/58 |
| Non-cardiac chest painGeneral disorders | 3/8 | 1/8 | 0/8 | 1/20 | 0/82 | 0/58 |
| PalpitationsCardiac disorders | 1/8 | 0/8 | 2/8 | 0/20 | 2/82 | 2/58 |
| HypothyroidismEndocrine disorders | 1/8 | 2/8 | 0/8 | 0/20 | 2/82 | 0/58 |
| NauseaGastrointestinal disorders | 2/8 | 1/8 | 2/8 | 1/20 | 19/82 | 7/58 |
| Oedema peripheralGeneral disorders | 2/8 | 1/8 | 0/8 | 2/20 | 9/82 | 4/58 |
| PyrexiaGeneral disorders | 0/8 | 2/8 | 0/8 | 0/20 | 5/82 | 1/58 |
| BronchitisInfections and infestations | 1/8 | 2/8 | 2/8 | 0/20 | 2/82 | 0/58 |
| Upper respiratory tract infectionInfections and infestations | 0/8 | 0/8 | 2/8 | 0/20 | 2/82 | 5/58 |
| Folate deficiencyMetabolism and nutrition disorders | 0/8 | 2/8 | 0/8 | 0/20 | 4/82 | 4/58 |
The safety analysis set included all participants who received at least 1 dose of study drug.
| Age, Customized(Participants) | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg | DB Component: Roxadustat | DB Component: Placebo | Total |
|---|---|---|---|---|---|---|---|
| <65 Years | 3 | 0 | 2 | 8 | 18 | 14 | 45 |
| ≥65 Years | 5 | 8 | 6 | 12 | 64 | 44 | 139 |
| Sex: Female, Male(Participants) | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg | DB Component: Roxadustat | DB Component: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Female | 3 | 3 | 6 | 6 | 36 | 21 | 75 |
| Male | 5 | 5 | 2 | 14 | 46 | 37 | 109 |
| Ethnicity (NIH/OMB)(Participants) | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg | DB Component: Roxadustat | DB Component: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 0 | 1 | 1 | 2 | 6 |
| Not Hispanic or Latino | 7 | 7 | 6 | 19 | 78 | 55 | 172 |
| Unknown or Not Reported | 0 | 0 | 2 | 0 | 3 | 1 | 6 |
| Race (NIH/OMB)(Participants) | OL Component (Cohort 1): Roxadustat 1.5 mg/kg | OL Component (Cohort 2): Roxadustat 2.0 mg/kg | OL Component (Cohort 3): Roxadustat 2.5 mg/kg | OL High-EPO Component: Roxadustat 2.5 mg/kg | DB Component: Roxadustat | DB Component: Placebo | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 3 | 14 | 7 | 24 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 7 | 8 | 8 | 17 | 63 | 49 | 152 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 5 | 2 | 8 |
Showing the first 100 of 124 sites across 16 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Mar 2023, 61 months.
Results were first posted in Aug 2024, 1 year 4 months after primary completion. A results delay was requested in Feb 2024.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Roxadustat