Real-world evidence
From controlled trials to routine practice
A 2026 retrospective, multicentre observational study from six tertiary nephrology centres in India evaluated desidustat in routine clinical practice.
Observational evidence · Association during treatment, not randomised causality.
517 evaluable patients6 tertiary centres
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Cohort at a glance
Non-dialysis
371Dialysis-dependent
146Mean age
57.86yearsComorbidity
44.3%Diabetes · Hypertension 61.3%2
Haemoglobin over six months
Within-patient change during treatment; p<0.005 for all reported comparisons.
Mean Hb (g/dL)
Non-dialysis view
9.11 → 10.13Baseline to Month 6 · n=371Dialysis-dependent view
9.06 → 9.93Baseline to Month 6 · n=146i
The between-group difference in haemoglobin change was not statistically significant. Results reflect association during treatment in routine practice.
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What routine practice looked like
88%
Most received 100 mg
88.18%100 mg three times weeklyObserved practice may vary by patient and centre. Always use the approved PI for dosing.
Review approved dosingIron according to need
Iron was prescribed according to clinical need during routine care.
0
No documented toxicity discontinuations
No discontinuations due to drug-related toxicity were documented in the available records.
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Tolerability
AE
Mild events reported
Mild events such as constipation and throat discomfort were reported.
✓
No new safety signals reported
No new safety signals were reported during the observation period.
See approved safety informationi
Observational safety findings are not a substitute for the approved PI or clinical judgement.
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Read the limitations before the conclusion
Desi
Retrospective design
- No randomised comparator
- Incomplete records were excluded
- Potential selection bias
Bias
Confounding and under-reporting
- Possible confounding
- Adverse events may be under-reported
- Practices varied across centres
Gap
Outcomes still needed
- No systematic patient-reported outcomes
- Longer cardiovascular follow-up needed
- Prospective research needed
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What this means
A routine-practice signal
Desidustat use was associated with sustained haemoglobin improvement across non-dialysis and dialysis-dependent patients over six months.
A complement to clinical trials
Real-world evidence shows how treatments perform in everyday practice but cannot establish the same causal certainty as a randomised trial.
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Related controlled evidence
ND
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