Trial reportKidney3602021
Safety and Efficacy of Tenapanor for Long-term Serum Phosphate Control in Maintenance Dialysis: A 52-Week Randomized Phase 3 Trial (PHREEDOM).
Trial report in Kidney360, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03427125 (A 26-Wk, Phase 3, Open Label), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A 26-Wk, Phase 3, Open Label (OL) Study With a 12-Wk, Placebo-Controlled, Randomized Withdrawal Period and an OL Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in CKD Patients on Dialysis
Who cites it
21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD).The Cochrane database of systematic reviews · 2025Pooled it
- Efficacy and safety of tenapanor vs placebo in treating CKD patients on dialysis and with hyperphosphatemia: a systematic review and meta-analysis of 2251 patients.International urology and nephrology · 2025Pooled it
- Efficacy and safety of tenapanor in end-stage renal disease patients with hyperphosphatemia: a systematic review and meta-analysis.Renal failure · 2024Pooled it
- Tenapanor for peritoneal dialysis patients with hyperphosphatemia: a phase 3 trial.Clinical and experimental nephrology · 2024Trial
- Long-term safety and decrease of pill burden by tenapanor therapy: a phase 3 open-label study in hemodialysis patients with hyperphosphatemia.Scientific reports · 2023Trial
- Tenapanor Beyond Phosphate: Gut Sodium Transport, Stool Transit Time, and Volume Balance in Dialysis Patients.Hemodialysis international. International Symposium on Home Hemodialysis · 2026Review
- Renoprotective effects of gut NHE3 inhibitor tenapanor in a rat model of unilateral renal ischemia-reperfusion injury with contralateral nephrectomy.Biochemistry and biophysics reports · 2026Article
- Emerging treatments and current strategies for mineral, vascular, and bone disorders in chronic kidney disease.World journal of nephrology · 2026Review
- The Impact of Tenapanor on Serum Phosphate in Adult Dialysis Patients: A Narrative Review.Kidney medicine · 2026Review
- Article
- Treatment Satisfaction with Tenapanor: Real-World Survey of Patients with End-Stage Renal Disease and Hyperphosphatemia.Patient preference and adherence · 2026Article
- Efficacy and Safety of Phosphate-Lowering Agents for Adult Patients with CKD Requiring Dialysis: A Network Meta-Analysis.Clinical journal of the American Society of Nephrology : CJASN · 2025Article
- A Pan-Inhibitor of Phosphate Transporters AP306 in Hemodialysis Patients.Kidney international reports · 2025Article
- Tenapanor: A novel therapeutic agent for dialysis patients with hyperphosphatemia.Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2025Review
- Hyperphosphatemia in Chronic Kidney Disease: The Search for New Treatment Paradigms and the Role of Tenapanor.International journal of nephrology and renovascular disease · 2024Review
- Pharmacology of Mammalian NaHandbook of experimental pharmacology · 2024Article
- Tenapanor in Chinese ESRD patients with hyperphosphatemia on haemodialysis: a randomised, phase 3 trial.Clinical kidney journal · 2024Article
- Tenapanor as Add-on Treatment for Hyperphosphatemia in Dialysis Patients: Enough Bang for the Buck?Kidney international reports · 2023Article
- Constipation in Patients With Chronic Kidney Disease.Journal of neurogastroenterology and motility · 2023Review
- Physiopathology of Phosphate Disorders.Advances in kidney disease and health · 2023Review
Corrections and comments
- Erratum issued
Authors and funding
8 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Treating hyperphosphatemia is a tenet of dialysis care. This trial assessed the safety and efficacy of tenapanor for the management of hyperphosphatemia. Methods: In this 52-week phase 3 study (NCT03427125), participants receiving maintenance dialysis with both hyperphosphatemia (serum phosphate 6.0-10.0 mg/dl) and a 1.5 mg/dl increase after phosphate binder washout were randomized (3:1) to tenapanor 30 mg twice daily for 26 weeks (randomized treatment period) or sevelamer carbonate (52-week safety control). Participants completing 26 weeks of treatment with tenapanor were rerandomized (1:1) to tenapanor or placebo for 12 weeks (randomized withdrawal period), and were eligible to enter the 14-week safety extension period. With input from the US Food and Drug Administration, the primary efficacy end point was the difference in the change in serum phosphate from the end of the randomized treatment period to the end of the randomized withdrawal period, among participants who achieved ≥1.2 mg/dl decrease in serum phosphate during the randomized treatment period (efficacy analysis set). Efficacy was also evaluated in the intention-to-treat (ITT) analysis set. Results: Of 564 eligible participants randomized to receive tenapanor ( Conclusions: Tenapanor reduced serum phosphate concentrations and maintained control of serum phosphate in participants receiving maintenance dialysis, with an acceptable safety and tolerability profile.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.