{"id":"velphoro","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT03824587","NCT04485039","NCT02687594","NCT02688764","NCT03010072","NCT04046263","NCT03644264","NCT03409757","NCT06911034"],"aliases":["Sucroferric oxyhydroxide"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"brandName":"Velphoro","companyId":"rwth-aachen-university","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Small molecule","drugClass":"","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"RWTH Aachen University","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"Velphoro","indications":{"approved":[{"name":"Hyperphosphatemia","diseaseId":"hyperphosphatemia","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03824587","phase":"Phase 2","title":"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosph","status":"COMPLETED","sponsor":"Ardelyx","isPivotal":true,"enrollment":236,"indication":"Hyperphosphatemia","completionDate":"2019-07-17"},{"nctId":"NCT04485039","phase":"Phase 4","title":"A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects","status":"COMPLETED","sponsor":"SIGA Technologies","isPivotal":false,"enrollment":44,"indication":"Smallpox","completionDate":"2023-04-23"},{"nctId":"NCT02687594","phase":"N/A","title":"Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis or Peritoneal D","status":"COMPLETED","sponsor":"Vifor Fresenius Medical Care Renal Pharma","isPivotal":false,"enrollment":1400,"indication":"Hyperphosphatemia","completionDate":"2019-04-06"},{"nctId":"NCT02688764","phase":"Phase 3","title":"An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Ad","status":"TERMINATED","sponsor":"Vifor Fresenius Medical Care Renal Pharma","isPivotal":true,"enrollment":85,"indication":"Hyperphosphatemia","completionDate":"2019-02-21"},{"nctId":"NCT03010072","phase":"Phase 2","title":"The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum","status":"COMPLETED","sponsor":"Prim. Priv. Doz. Dr. Daniel Cejka","isPivotal":false,"enrollment":40,"indication":"Endstage Renal Disease","completionDate":"2019-05-10"},{"nctId":"NCT04046263","phase":"Phase 4","title":"Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients","status":"COMPLETED","sponsor":"University of Colorado, Denver","isPivotal":false,"enrollment":17,"indication":"Peritoneal Dialysis Complication, Hyperphosphatemia","completionDate":"2021-07-31"},{"nctId":"NCT03644264","phase":"Phase 3","title":"An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 and Sevelamer Carbonate (Renvela®) in Chinese CKD Patients With ","status":"COMPLETED","sponsor":"Vifor Fresenius Medical Care Renal Pharma","isPivotal":true,"enrollment":286,"indication":"Chronic Kidney Disease Requiring Chronic Dialysis, Hyperphosphatemia","completionDate":"2020-08-21"},{"nctId":"NCT03409757","phase":"N/A","title":"Velphoro and Impact on the Oral Cavity and Gut Microbiome","status":"TERMINATED","sponsor":"RWTH Aachen University","isPivotal":false,"enrollment":22,"indication":"Hyperphosphatemia","completionDate":"2020-10-06"},{"nctId":"NCT06911034","phase":"Phase 4","title":"Comparison of Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anemia in Pregnant Women","status":"COMPLETED","sponsor":"CMH Multan Institute of Medical Sciences","isPivotal":false,"enrollment":60,"indication":"Iron Deficiency Anemia (IDA), Pregnancy","completionDate":"2024-09-30"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Other"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","aiSummary":"","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}