CompletedPhase 2

Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa

United States175 participantsStarted 2019-01-31

Plain-language summary

This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Main study: Mean weekly Epoetin Alfa dose \<300 Units per kilogram per week (U/kg/week) for 8 weeks prior to SV2;
✓. ESA hyporesponder parallel study: Mean weekly Epoetin Alfa dose ≥300 U/kg/week for 8 weeks prior to SV2
✓. Main study: 2 Hb values between 8.5 and 11.0 g/dL, inclusive;
✓. ESA hyporesponder parallel study: 2 Hb values between 8.0 and 10.0 grams per deciliter (g/dL), inclusive

Exclusion criteria

✕. inability to confirm surgical sterility (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 1 month prior to Screening;
✕. not considered post-menopausal (no menses for \>1 year with follicle stimulating hormone \>40 U/Liter at Screening)
✕. lack of confirmation of the use of acceptable forms of contraception\* for a minimum of one complete menstrual cycle prior to Screening;
✕. positive serum pregnancy test at SV2;
✕. unwilling to use two acceptable forms of contraception\* (at least one of which must be a barrier method) starting Baseline/Day 1, throughout the Treatment Period and for 30 days after the final study drug administration

What they're measuring

Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)

Timeframe: Baseline; Week 10 to Week 12

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to Week 24

Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values

Timeframe: Up to Week 24

Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values

Timeframe: Up to Week 24

Number of Participants Classified as Hb Outliers

Timeframe: Weeks 13 - 20

Trial details

NCT IDNCT03799627

SponsorAkebia Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-05

Results submitted2022-04-27

View on ClinicalTrials.gov More Anemia trials

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Main study: Mean weekly Epoetin Alfa dose \<300 Units per kilogram per week (U/kg/week) for 8 weeks prior to SV2;
✓. ESA hyporesponder parallel study: Mean weekly Epoetin Alfa dose ≥300 U/kg/week for 8 weeks prior to SV2
✓. Main study: 2 Hb values between 8.5 and 11.0 g/dL, inclusive;
✓. ESA hyporesponder parallel study: 2 Hb values between 8.0 and 10.0 grams per deciliter (g/dL), inclusive

Exclusion criteria

✕. inability to confirm surgical sterility (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 1 month prior to Screening;
✕. not considered post-menopausal (no menses for \>1 year with follicle stimulating hormone \>40 U/Liter at Screening)
✕. lack of confirmation of the use of acceptable forms of contraception\* for a minimum of one complete menstrual cycle prior to Screening;
✕. positive serum pregnancy test at SV2;
✕. unwilling to use two acceptable forms of contraception\* (at least one of which must be a barrier method) starting Baseline/Day 1, throughout the Treatment Period and for 30 days after the final study drug administration

What they're measuring

Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)

Timeframe: Baseline; Week 10 to Week 12

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to Week 24

Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values

Timeframe: Up to Week 24

Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values

Timeframe: Up to Week 24

Number of Participants Classified as Hb Outliers

Timeframe: Weeks 13 - 20