A Phase 3 interventional study of Vadadustat and Mircera® in Anemia Associated With Chronic Kidney Disease (CKD), sponsored by Akebia Therapeutics. Completed at 58 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Akebia Therapeutics · Phase 3, Interventional, and Treatment
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.
Following randomization, there will be 2 periods during the study:
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This study's enrollment of 456 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 600 milligrams (mg).
Drug: Vadadustat
Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 900 mg.
Drug: Vadadustat
Participants will continue to receive Mircera® for up to 52 weeks.
Drug: Mircera®
oral tablets
intravenous administration
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)
The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.
Time frame: Baseline; Weeks 20 to 26
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)
The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value.
Time frame: Baseline; Weeks 46 to 52
This was a randomzied, open-label, active-controlled study of the efficacy and safety of conversion from long-acting Erythropoiesis-stimulating Agent (ESA) (Methoxy polyethylene glycol-epoetin beta \[Mircera®\]) to vadadustat Three Times Weekly (TIW) for the maintenance treatment of anemia in hemodialysis participants.
| Milestone | Vadadustat 600 mg TIW | Vadadustat 900 mg TIW | Mircera® |
|---|---|---|---|
| Started | 152 | 152 | 152 |
| Completed | 99 | 98 | 118 |
| Not completed | 53 | 54 | 34 |
| Withdrew: Adverse event | 9 | 18 | 3 |
| Withdrew: Investigator's discretion | 8 | 4 | 3 |
| Withdrew: Withdrawal by subject | 6 | 8 | 2 |
| Withdrew: Lack of efficacy | 1 | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 3 |
| Withdrew: Death | 13 | 11 | 13 |
| Withdrew: Protocol violation | 2 | 1 | 0 |
| Withdrew: Non compliance with study drug | 1 | 0 | 0 |
| Withdrew: Transplant | 4 | 4 | 8 |
| Withdrew: Other | 9 | 5 | 2 |
The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.
| Grams per deciliter (g/dL) | Vadadustat 600 mg TIW | Vadadustat 900 mg TIW | Mircera® |
|---|---|---|---|
| Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26) | -0.07 ± 0.095 | 0.14 ± 0.095 | 0.36 ± 0.092 |
The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value.
| Grams per deciliter | Vadadustat 600 mg TIW | Vadadustat 900 mg TIW | Mircera® |
|---|---|---|---|
| Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52) | -0.11 ± 0.110 | -0.22 ± 0.123 | 0.16 ± 0.102 |
Collected over Day 1 through Week 56. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vadadustat 600 mg TIW | 14/151 (9.3%) | 68/151 (45%) | 61/151 (40.4%) |
| Vadadustat 900 mg TIW | 12/150 (8%) | 66/150 (44%) | 67/150 (44.7%) |
| Mircera® | 17/150 (11.3%) | 67/150 (44.7%) | 64/150 (42.7%) |
| Event | Vadadustat 600 mg TIW | Vadadustat 900 mg TIW | Mircera® |
|---|---|---|---|
| Cardiac arrestCardiac disorders | 2/151 | 3/150 | 11/150 |
| COVID 19 pneumoniaInfections and infestations | 1/151 | 4/150 | 8/150 |
| PneumoniaInfections and infestations | 4/151 | 7/150 | 2/150 |
| HypervolaemiaMetabolism and nutrition disorders | 7/151 | 6/150 | 4/150 |
| COVID 19Infections and infestations | 3/151 | 5/150 | 6/150 |
| Acute myocardial infarctionCardiac disorders | 4/151 | 3/150 | 5/150 |
| HyperkalaemiaMetabolism and nutrition disorders | 4/151 | 4/150 | 5/150 |
| Arteriovenous graft thrombosisInjury, poisoning and procedural complications | 1/151 | 3/150 | 5/150 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 4/151 | 5/150 | 5/150 |
| Cardiac failure congestiveCardiac disorders | 5/151 | 2/150 | 1/150 |
| Event | Vadadustat 600 mg TIW | Vadadustat 900 mg TIW | Mircera® |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 16/151 | 21/150 | 11/150 |
| COVID 19Infections and infestations | 19/151 | 18/150 | 19/150 |
| NauseaGastrointestinal disorders | 12/151 | 13/150 | 7/150 |
| HyperkalaemiaMetabolism and nutrition disorders | 6/151 | 13/150 | 12/150 |
| FallInjury, poisoning and procedural complications | 11/151 | 8/150 | 11/150 |
| HypertensionVascular disorders | 5/151 | 4/150 | 11/150 |
| HeadacheNervous system disorders | 3/151 | 10/150 | 5/150 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 9/151 | 8/150 | 4/150 |
| Arteriovenous fistula site complicationInjury, poisoning and procedural complications | 7/151 | 8/150 | 7/150 |
| VomitingGastrointestinal disorders | 4/151 | 5/150 | 8/150 |
Randomized population included all randomized participants.
| Age, Continuous(Years) | Vadadustat 600 mg TIW | Vadadustat 900 mg TIW | Mircera® | Total |
|---|---|---|---|---|
| Mean | 59.4 ± 14.20 | 61.9 ± 13.27 | 61.6 ± 12.80 | 61.0 ± 13.45 |
| Sex: Female, Male(Participants) | Vadadustat 600 mg TIW | Vadadustat 900 mg TIW | Mircera® | Total |
|---|---|---|---|---|
| Female | 68 | 60 | 66 | 194 |
| Male | 84 | 92 | 86 | 262 |
| Ethnicity (NIH/OMB)(Participants) | Vadadustat 600 mg TIW | Vadadustat 900 mg TIW | Mircera® | Total |
|---|---|---|---|---|
| Hispanic or Latino | 42 | 40 | 56 | 138 |
| Not Hispanic or Latino | 110 | 109 | 95 | 314 |
| Unknown or Not Reported | 0 | 3 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Vadadustat 600 mg TIW | Vadadustat 900 mg TIW | Mircera® | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 5 | 3 | 4 | 12 |
| Asian | 3 | 2 | 3 | 8 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 56 | 59 | 53 | 168 |
| White | 86 | 87 | 92 | 265 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
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Akebia Therapeutics