Summary
Iron Sucrose has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Kidney Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Kidney Disease. ClinicalTrials.gov lists 8 registered trials linking Iron Sucrose to Chronic Kidney Disease: 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05691257). It plans or enrolled 300 participants. Registration activity spans 2006 to 2023. The literature layer holds 6 publications for this pair: 1 Cochrane review and 5 clinical trial publications. Publication years run from 2016 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Chronic Kidney Disease ranks 534 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: GFR decline averages 2-5 mL/min/year on standard care (ACE/ARB + blood pressure control); progression to end-stage renal disease (ESRD) in ~20-30% at 10 years for moderate CKD; reversal essentially impossible once structural fibrosis established.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 61.0 (trials 26.0, literature 15.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 4 completed, 3 other |
| Linked publications | 6 (5 clinical trial publications, 1 Cochrane review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT02392910 | Hospitalization & Mortality in Patients With Iron Deficiency CKD and HF Treated With i.v. Iron. 2006 | completed | Phase 4 | 40 |
| NCT06556134 | Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients 2021 | completed | Phase 4 | 27 |
| NCT00830037 | A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease 2008 | terminated | Phase 4 | 136 |
| NCT05691257 | Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia 2023 | status unknown | Phase 4 | 300 |
| NCT03619850 | A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD) 2018 | recruiting | Phase 3 | 129 |
| NCT01414075 | Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment 2011 | completed | Phase 2 | 60 |
| NCT00318812 | Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure 2007 | completed | PHASE2, PHASE3 | 55 |
| NCT03214627 | Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial 2018 | terminated | Not applicable | 88 |
Published literature
- Clinical trial publication Recurrent event analyses in patients receiving maintenance dialysis and the effect of higher- versus lower-dose chronic intravenous iron therapy: A report focusing on heart failure events from the PIVOTAL trialAnker SD, Robertson M, McMurray JJV et al. · European journal of heart failure · 2025 · PMID 40393927
- Clinical trial publication Comparison of Iron Dosing Strategies in Patients Undergoing Long-Term Hemodialysis: A Randomized Controlled TrialBielesz B, Lorenz M, Monteforte R et al. · Clinical journal of the American Society of Nephrology : CJASN · 2021 · PMID 34470831
- Clinical trial publication Safety and Efficacy of Intravenous Ferric Derisomaltose Compared to Iron Sucrose for Iron Deficiency Anemia in Patients with Chronic Kidney Disease With and Without Heart FailureAmbrosy AP, von Haehling S, Kalra PR et al. · The American journal of cardiology · 2021 · PMID 34162484
- Clinical trial publication Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trialBhandari S, Kalra PA, Berkowitz M et al. · Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021 · PMID 32049331
- Clinical trial publication Conversion of haemodialysis patients from iron sucrose to iron isomaltoside: a real-world experienceJesus-Silva JA, Lamplugh A, Dhada S et al. · BMC nephrology · 2020 · PMID 32493240
- Cochrane review Intravenous Versus Oral Iron Supplementation for the Treatment of Anemia in CKD: An Updated Systematic Review and Meta-analysisShepshelovich D, Rozen-Zvi B, Avni T et al. · American journal of kidney diseases : the official journal of the National Kidney Foundation · 2016 · PMID 27321965
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Iron Sucrose approved for Chronic Kidney Disease?
Iron Sucrose has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Kidney Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Kidney Disease. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Iron Sucrose in clinical trials for Chronic Kidney Disease?
ClinicalTrials.gov lists 8 registered trials linking Iron Sucrose to Chronic Kidney Disease: 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05691257). It plans or enrolled 300 participants. Registration activity spans 2006 to 2023.
What does the evidence show for Iron Sucrose in Chronic Kidney Disease?
Iron Sucrose has both completed registered trials and synthesis-level publications linked to Chronic Kidney Disease. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.