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NCT02858726 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

A Phase 2 study, sponsored by Cara Therapeutics.

Completed
Registry status
Phase 2
Development phase
226
Enrollment target

NCT02858726 is a Phase 2 study that has completed, run by Cara Therapeutics. The registered enrollment target is 226 participants.

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The verdict

NCT02858726, a Phase 2 study, has completed, sponsored by Cara Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
226 participants
Enrollment target

Study Summary

2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients will receive either CR845 or placebo after each dialysis session for eight weeks. The safety and efficacy of CR845 will be monitored throughout the study. A sub-group of patients will also have pharmacokinetic assessments completed. Part B of the study will assess one dose of IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe itching. The dose of CR845 used in Part B will be based on safety and efficacy found in Part A.

Interventions

  • DRUG Placebo
  • DRUG CR845 0.5 mcg/kg
  • DRUG CR845 1 mcg/kg
  • DRUG CR845 1.5mcg/kg

Trial Details

FieldValue
Enrollment Target 226 participants
Start Date 2016-06
Est. Completion 2017-03-14
Phase Phase 2

Sponsor

Cara Therapeutics

23 total trials

What the Registry Record Tells You About NCT02858726

The ClinicalTrials.gov registry entry for NCT02858726 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cara Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02858726 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02858726 about?

NCT02858726 is a clinical study titled "Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus". 2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients will receive either CR845 or placebo after each dialysis session for eight weeks. The safety and efficacy of CR845 wil...

What is the current status of trial NCT02858726?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 226 participants. The study started on 2016-06. Estimated completion is 2017-03-14.

What interventions are being tested in trial NCT02858726?

The interventions under investigation include: Placebo (DRUG), CR845 0.5 mcg/kg (DRUG), CR845 1 mcg/kg (DRUG), CR845 1.5mcg/kg (DRUG).

Who is sponsoring clinical trial NCT02858726?

This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.