An AllTrials project

NCT05356403: An overdue trial by Cara Therapeutics, Inc.

This trial is overdue. It was due to report 9 months, 3 weeks ago.

Think we've made a mistake? Before contacting us, review the criteria in our paper. In particular, bear in mind the following:

  • We can only rely on the structured data that sponsors put into the registry: they may enter incorrect or incomplete data.
  • Reporting in a journal is not enough. The FDAAA rules state that the trial must be reported on ClinicalTrials.gov.
  • Terminated trials are required to report results. Only withdrawn trials (which never recruited a single patient) are not.

Full data

Full entry on ClinicalTrials.gov NCT05356403
Title A Multicenter, Randomized, Double-blind, Placebo-controlled 12-Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects With Moderate-to-Severe Pruritus With an up to 52-Week Long-term Extension
Results Status Overdue
ACT or pACT? This is what FDAAA officially calls an "Applicable Clinical Trial"
Start date Aug. 26, 2022
Completion date Feb. 26, 2024
Required reporting date Feb. 25, 2025, midnight
Actual reporting date None
Date last checked at ClinicalTrials.gov Dec. 12, 2025
Days late 289