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Dr. Grey AI

Peptide

Peginesatide (Omontys)

Peginesatide is a synthetic PEGylated dimeric peptide erythropoiesis-stimulating agent for renal anemia. FDA-approved March 2012. WITHDRAWN February 2013 due to fatal anaphylaxis (0.02% rate). EMERALD trials (n=1608): Once-monthly peginesatide noninferior to epoetin for hemoglobin maintenance in dialysis patients. PEARL trials: Cardiovascular events and mortality INCREASED in non-dialysis CKD patients vs darbepoetin. Unique: No structural homology to erythropoietin - effective even with anti-EPO antibodies. SAFETY CONCERN: Fatal anaphylactic reactions led to worldwide market withdrawal. For educational/historical reference only.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
1
Outcomes
7
Graded outcomes
3301

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

1 condition, plus general outcomes

Renal Anemia

Renal Anemia: outcomes studied for Peginesatide (Omontys)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Hemoglobin Maintenance (Dialysis)

EMERALD 1+2 trials (n=1608): Once-monthly peginesatide noninferior to epoetin (1-3x weekly) for maintaining Hgb 10-12 g/dL over 52+ weeks. Similar mean Hgb levels. Similar transfusion requirements. Approved only for dialysis patients.

NoneNo effect8 studies

Studies that measured hemoglobin maintenance (dialysis)

Cardiovascular Safety (Non-Dialysis)

SAFETY CONCERN - PEARL trials (n=1066 non-dialysis CKD): Cardiovascular events and mortality INCREASED with peginesatide vs darbepoetin. FDA declined approval for non-dialysis patients. Mechanism unclear - may relate to higher dose requirements.

Worsens (the measure goes down)Moderate effect5 studies

Studies that measured cardiovascular safety (non-dialysis)

Anaphylaxis Risk

SAFETY CONCERN - DRUG WITHDRAWN: Post-marketing: 0.2% severe allergic reactions, 0.02% fatal anaphylaxis rate. 13 cases of serious hypersensitivity within 30 min of first dose reported. Voluntary worldwide recall February 2013 - 11 months after FDA approval.

Worsens (the measure goes up)Moderate effect
Pure Red Cell Aplasia Treatment

Unique application: Effective in anti-EPO antibody-mediated pure red cell aplasia (PRCA) due to no structural homology to EPO. Could stimulate erythropoiesis in heavily transfusion-dependent PRCA patients who failed all recombinant EPO therapies.

Improves (the measure goes up)Large effect

General

General: outcomes studied for Peginesatide (Omontys)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Kidney Function

19 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect10 studies

Studies that measured kidney function

Safety/Tolerability

7 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Small effect7 studies

Studies that measured safety/tolerability

Anti-Aging

2 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect2 studies

Studies that measured anti-aging

Key findings

  • Hemoglobin Maintenance (Dialysis)Renal Anemia
  • Cardiovascular Safety (Non-Dialysis)Renal AnemiaWorsens (the measure goes down)
  • Anaphylaxis RiskRenal AnemiaWorsens (the measure goes up)

Studies cited

24 studies from PubMed

  1. Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions.Journal of pharmaceutical sciences, 2018 · PMID 29409840
  2. Investigating Serious Adverse Drug Reactions in Patients Receiving Erythropoiesis-Stimulating Agents: A Root Cause Analysis Using the "ANTICIPATE" Framework.American journal of therapeutics, 2018 · PMID 30169374
  3. Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product Are Associated With Severe Adverse Postmarketing Events.Journal of pharmaceutical sciences, 2016 · PMID 26886324
  4. Peginesatide to manage anemia in chronic kidney disease patients on peritoneal dialysisPerit Dial Int, 2014 · PMID 24584613
  5. Relative safety of peginesatide and epoetin alfa.Pharmacoepidemiology and drug safety, 2014 · PMID 24905967
  6. Peginesatide in patients with anemia undergoing hemodialysisN Engl J Med, 2013 · PMID 23343061
  7. Peginesatide for anemia in patients with chronic kidney disease not receiving dialysisN Engl J Med, 2013 · PMID 23343062
  8. Peginesatide for the treatment of renal disease-induced anemiaExpert Opin Pharmacother, 2013 · PMID 23506424
  9. Managing dialysis patients who develop anemia caused by chronic kidney disease: focus on peginesatideInt J Nanomedicine, 2013 · PMID 24023516
  10. On peginesatide and anemia treatment in CKDAm J Kidney Dis, 2013 · PMID 23810692
  11. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease.Drugs, 2013 · PMID 23338536
  12. Anemia treatment in patients with chronic kidney disease.The New England journal of medicine, 2013 · PMID 23343068
  13. Peginesatide for anemia in chronic kidney disease.The New England journal of medicine, 2013 · PMID 23594010
  14. Anaemia: The safety and efficacy of peginesatide in patients with CKD.Nature reviews. Nephrology, 2013 · PMID 23478418
  15. Dose-finding study of peginesatide for anemia correction in chronic kidney disease patientsNephrol Dial Transplant, 2012 · PMID 21940838
  16. New blood-boosting drugs aim to staunch renal anemia.Nature medicine, 2012 · PMID 22395683
  17. New strategies for managing anemia of chronic kidney disease.Cardiovascular & hematological agents in medicinal chemistry, 2012 · PMID 22642238
  18. Peginesatide (Omontys) for anemia in chronic kidney failure.The Medical letter on drugs and therapeutics, 2012 · PMID 22683926
  19. Profile of peginesatide and its potential for the treatment of anemia in adults with chronic kidney disease who are on dialysis.Journal of blood medicine, 2012 · PMID 22719216
  20. Peginesatide for the treatment of anemia in the nephrology setting.Drugs of today (Barcelona, Spain : 1998), 2012 · PMID 22745925
  21. A review of safety, efficacy, and utilization of erythropoietin, darbepoetin, and peginesatide for patients with cancer or chronic kidney disease: a report from the Southern Network on Adverse Reactions (SONAR).Seminars in thrombosis and hemostasis, 2012 · PMID 23111861
  22. Peginesatide: a potential erythropoiesis stimulating agent for the treatment of anemia of chronic renal failureDrugs Today (Barc), 2011 · PMID 21290916
  23. Genotoxic assessment and toxicity evaluation of peginesatide in CByB6F1 hybrid mice.Drug and chemical toxicology, 2011 · PMID 21649477
  24. Chronic kidney disease-associated anemia: new remedies.Current opinion in investigational drugs (London, England : 2000), 2010 · PMID 20730698