DREAM-ND (India Phase III)
- 588 adults with anaemia due to CKD
- Stage 3–5 CKD not requiring dialysis
- Baseline haemoglobin 7.0–10.0 g/dL
- Randomised 1:1: Desidustat vs Darbepoetin alfa
Open-label, active-controlled, non-inferiority trial
Why anaemia management becomes challenging before dialysis
Anaemia worsens as CKD advances
Anaemia prevalence and severity increase as kidney function declines.
Complex causes
Reduced EPO production, inflammation and higher hepcidin limit iron availability even when iron stores are normal.
Treatment burden with injections
Injectable ESAs require clinic visits, skilled administration and cold-chain storage.
Oral options may be more acceptable
Guidelines note oral administration was thought more acceptable overall, though adherence and evidence certainty remain considerations.
Who the evidence studied
China Phase III (Placebo-controlled)
- 152 adults with NDD-CKD anaemia
- Baseline haemoglobin ≤ 10.5 g/dL
- Randomised 2:1: Desidustat vs Placebo
Double-blind, placebo-controlled trial
Trial criteria are not the same as a prescribing decision. Your doctor will decide what is right for you.
Efficacy snapshot
DREAM-ND (India Phase III)
- Study design
- 24-week, randomised, open-label, active-controlled, non-inferiority
- Mean Hb change (Weeks 16–24)
- Desidustat: 1.95 g/dL
- Darbepoetin alfa: 1.83 g/dL
- Hb responders
- 77.78% vs 68.48%
- p = 0.0181
China Phase III (Placebo-controlled)
- Study design
- Double-blind, placebo-controlled (Week 7–9 primary period)
- Mean Hb difference (Weeks 7–9)
- 17.52 g/L favouring desidustat vs placebo
- Hb response
- 85.15% vs 23.53% vs placebo
- Safety
- Comparable TEAE incidence during the reported period
Results are from clinical studies. Individual results may vary.
Mechanism-relevant biomarkers
Hepcidin reductions observed
- DREAM-ND: Hepcidin decreased significantly vs darbepoetin by Week 9.
- China Phase III: Hepcidin decreased vs placebo by Week 9.
No significant VEGF change
In DREAM-ND, there was no statistically significant between-group difference in VEGF change at Weeks 12 and 24.
View VEGF dataLipids (LDL)
Findings on LDL were secondary/exploratory in DREAM-ND. Do not assume broad benefit on cardiovascular outcomes.
View detailsBiomarker effects should not be automatically translated into improved patient outcomes.
From mechanism to evidence
Non-dialysis evidence (DREAM-ND)
Desidustat improved Hb with non-inferiority to darbepoetin over 24 weeks.
Explore NDD evidenceDialysis evidence (DREAM-D)
Desidustat was non-inferior to alfa over 16–24 weeks in dialysis patients.
Explore DD evidenceReal-world evidence
Observational studies suggest effectiveness and tolerability in routine practice.
Explore real-world dataGuideline & evidence context
South Asia HIF-PHI Guideline
- Desidustat might be offered as an alternative to ESAs for NDD patients with CKD stages 3–5 who do not prefer ESAs.
- Patients should be iron replete before initiation.
- Effectiveness and safety evidence was judged low certainty.
- More large, multicentre and long-term studies are recommended.
Safety summary & next steps
In clinical studies, desidustat was generally well tolerated. The safety profile was comparable to active comparator (DREAM-ND) and placebo (China Phase III) in the reported study periods.
View complete safety informationSee the study designs, results and important limitations.
Explore clinical evidencePrepare for an informed conversation with your nephrologist.
Download questions to askView approved indication and PI
See full prescribing information for OXEMIA® (desidustat).