CompletedPhase 3

Desidustat in the Treatment of Anemia in CKD on Dialysis Patients

India392 participantsStarted 2020-01-04

Plain-language summary

A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of anemia in patients with CKD on dialysis. (DREAM-D)

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patients will be considered not treated with erythropoietin analogue (Epoetin and Darbepoeitin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera® for at least 8 weeks prior to screening visit. OR
✓. Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment (≤30% of dose change).

Exclusion criteria

✕. Red blood cell transfusion within 8 weeks prior to participating in the study.
✕. History of previous or concurrent cancer.
✕. Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
✕. Active infection at initiation of study.
✕. History of renal transplant.
✕. Uncontrolled hypertension (defined as SBP \>180 mmHg or DBP \>100 mmHg) at screening visit (before dialysis).
✕. Patient on high rhEPO dose at screening visit. \[High dose defined as an epoetin dose of ≥450 IU/kg/week intravenous or ≥ 300 IU/kg/week subcutaneous or darbepoetin dose of ≥1.5 µg/kg/week subcutaneous\].
✕. Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.

What they're measuring

Hemoglobin level

Timeframe: 24 weeks

Trial details

NCT IDNCT04215120

SponsorZydus Lifesciences Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-02

View on ClinicalTrials.gov More Chronic Kidney Disease Stage 5 on Dialysis trials