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 range

18 Years – 99 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 99 Years

Sex

ALL

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