Non-dialysis-dependent CKD

An oral treatment option for adults with CKD anaemia not on dialysis

OXEMIA® (desidustat) is an oral HIF-PH inhibitor taken three times a week for anaemia in adults with CKD who are not receiving dialysis.

Rx

Indicated for the treatment of anaemia in adult patients with chronic kidney disease not requiring dialysis.

Review non-dialysis dosingRead DREAM-ND study
Adult patient taking an oral medicine with water
2

Why anaemia management becomes challenging before dialysis

1
CKD

Anaemia worsens as CKD advances

Prevalence and severity increase as kidney function declines.

2

Complex causes

Reduced EPO, inflammation and higher hepcidin can limit available iron.

3
ESA

Treatment burden with injections

Injected ESAs require visits, administration and cold-chain storage.

4

Oral options may be more acceptable

Oral administration may be more acceptable, while adherence and evidence certainty still matter.

i

Not every anaemia is caused by CKD. Diagnosis and treatment decisions should be made by a clinician.

3

Who the evidence studied

588
India Phase III

DREAM-ND

Adults with stage 3–5 CKD and haemoglobin 7.0–10.0 g/dL, not requiring dialysis.

n=58824 weeksDesidustat vs darbepoetin alfa
Read DREAM-ND
152
Placebo-controlled

China Phase III

Adults with non-dialysis CKD anaemia in a double-blind, placebo-controlled study.

n=15212 weeks2:1 randomisation
i

Trial criteria are not the same as a prescribing decision. A clinician decides what is right for an individual.

4

Efficacy snapshot

DREAM-ND · India Phase III

Active-controlled non-inferiority study

1.95 g/dLMean Hb change, Weeks 16–24
  • Darbepoetin alfa: 1.83 g/dL
  • Hb responders: 77.78% vs 68.48%
  • p=0.0181
View DREAM-ND study
China Phase III

Double-blind, placebo-controlled study

17.52 g/LBetween-group mean Hb difference, Weeks 7–9
  • Hb response: 85.15% vs 23.53%
  • Comparable TEAE incidence in the reported period
View evidence context
i

Results are from clinical studies. Individual results may vary.

5

Mechanism-relevant biomarkers

Hepcidin reductions observed

DREAM-ND reported a significant decrease versus darbepoetin by Week 9.

See hepcidin data
VEGF

No significant VEGF difference

No statistically significant between-group difference at Weeks 12 and 24.

LDL

Lipids were secondary or exploratory

LDL findings should not be assumed to prove cardiovascular benefit.

i

Biomarker effects should not automatically be translated into improved patient outcomes.

6

Dosing at a glance

Oral tablet

100 mgStarting dose
3×

Three times a week

Doses two days apart.

Dose adjustments

Review haemoglobin every four weeks.

MAX

Maximum dose

150 mgThree times a week

Administration

No food one hour before and two hours after.

i

Use the approved PI for the complete dosing and adjustment algorithm.

7

Guideline and evidence context

South Asia HIF-PHI Guideline

  • May be offered as an alternative to ESAs for appropriate NDD patients.
  • Patients should be iron replete before initiation.
  • Evidence was judged low certainty.
  • Larger, multicentre and long-term studies are recommended.
Read guideline context
12

Systematic review (NDD-CKD)

Evidence across HIF-PHIs was generally low or very low certainty for key clinical outcomes.

Review systematic evidence
8

Safety summary and next steps

Complete safety information

Review trial safety in context and the approved safety profile.

View safety

Approved indication and PI

Use the full prescribing information before prescribing.

Open PI