OXEMIA : Phase III Clinical Trials

CLINICAL TRIALS

Clinical Evidences of Desidustat
Phase III studies

DREAMND

Desidustat vs. Darbepoetin alfa Efficacy and safety comparision

Study Design:
A phase 3, multicenter, multi-country, open-label, randomised, active-controlled clinical trial.²⁰

Primary Endpoint:
Mean change in Hb levels from baseline (BL) to evaluation (Week 16 to Week 24) period in modified intent-to-treat (mITT) population.²⁰

N= 588 patients with (stages 3-5 CKD, aged 18-80 years old)*
*with a haemoglobin (Hb) level between 7-10 g/dL were randomised to receive either desidustat oral tablet or darbepoetin alfa injection for 24 week.²⁰

Dose: Desisutat 100 mg 3 times a week (2 days apart and not 4 days apart)²⁰

Duration: 24 weeks

Key Results: Primary endpoint analysis²⁰

Plot of 95% CI of difference (%) in Hb between Desidustat and Darbepoetin

Secondary Endpoint Analysis:²⁰

Change in Hepcidin value from baseline to week 12 and 24 for mITT and PP population

Greater reduction in Hepcidin level with Desidustat vs Darbepoetin alfa at 24th week

Desidustat was non-inferior compared to darbepoetin in non-dialysis patients

as represented by secondary end points, i.e., for time to achieve target Hb (p=0.2985), and for percentage time spent in target Hb range (p=0.1113).²⁰

Desidustat showed a significant reduction

(p = 0.0268) in low density lipoprotein (LDL)-cholesterol at Week 24 compared to baseline.²⁰

No change in VEGF from baseline to week 24²⁰

Safety Results:
The number of patients experiencing AEs during the trial do not significantly differ in the treatment and placebo arms.²⁰

Conclusion:
Desidustat was found to be non-inferior compared to darbepoetin in the treatment of anaemia in patients with CKD who were not on dialysis. The safety of desidustat is comparable to darbepoetin.²⁰

REFERENCES:

DREAMD

Desidustat vs. Epoetin alfa Efficacy and safety comparision

Study Design:
A phase 3, multicenter, open-label, randomised, active-controlled study²¹.

Primary Endpoint:
Primary efficacy endpoint was evaluation of difference of mean change of Hb from baseline (BL) to evaluation period (Week 16-24)²¹.

N=392 CKD patients (stage V) on dialysis*
*Subjects were randomised to recieve either Desidustat oral tablet or Epoetin injections for 24 weeks depending on previous ESA dose²¹.

Dose: Desidustat (100, 125, 150 mg) three times a week (2 days apart and not 4 days apart)²¹.

Duration: 24 weeks

Key Results: Primary endpoint analysis²¹

The change from baseline Hb (16-24 week)²¹:
Desidustat: 0.95 g/dl
Epoetin alfa: 0.80 g/dl

The lower limit of the 95% CI was above the predefined non-inferiority margin of –1.0 g/dL

Secondary Endpoint Analysis²¹:

Change in Hepcidin at Week 24

Greater reduction in Hepcidin level with Desidustat vs. Epoetin alfa at 24th week

Desidustat was superior compared to epoetin in dialysis patients

as represented by secondary end points, i.e., for time to achieve target Hb (p=0.041), and percentage of responders (p=0.038)²¹.

Desidustat showed a significant reduction in low density lipoprotein (LDL)-cholesterol

(p<0.0001) at Week 12 when compared to baseline²¹.

No change in VEGF from baseline to week 24²¹

Safety Results:
The number of patients experiencing AEs during the trial do not differ in both the arms²¹.

Conclusion:
Desidustat was found to be non-inferior compared to epoetin in the treatment of anaemia in patients with CKD who were on dialysis. The safety of desidustat is comparable to epoetin²¹.