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A Multicenter, Multidose, Study to Assess the Tolerability and Pharmacokinetics of Oxylanthanum Carbonate at Clinically Effective Doses in Patients With Chronic Kidney Disease on Dialysis

Trial Profile

A Multicenter, Multidose, Study to Assess the Tolerability and Pharmacokinetics of Oxylanthanum Carbonate at Clinically Effective Doses in Patients With Chronic Kidney Disease on Dialysis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Jul 2025

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At a glance

  • Drugs Lanthanum carbonate (Primary)
  • Indications Hyperphosphataemia
  • Focus Adverse reactions; Registrational
  • Sponsors Unicycive Therapeutics

Most Recent Events

  • 10 Jun 2025 According to a Unicycive Therapeutics media release, The FDA communicated to the Company that it had identified deficiencies in cGMP compliance at a third-party manufacturing vendor after an FDA inspection, any label discussions between the FDA and the Company are precluded. The Company has responded to all FDA information requests and expects a final decision from the FDA by the PDUFA action date of June 28, 2025.
  • 10 Apr 2025 According to Unicycive Therapeutics media release, Dr. Pablo Pergola is the principal investigator for the UNI-OLC-201 trial.
  • 10 Apr 2025 According to Unicycive Therapeutics media release, data from this study will be presented today in poster sessions at the NKF Spring Clinical Meetings taking place in Boston on Thursday, April 10, from 5:15-7:30 p.m. ET.

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