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Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus

NCT02229929 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2016-08-10

No results posted yet for this study

Summary

The primary purpose of this study is to:

* Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week in patients who are undergoing hemodialysis. (Part A)
* This study is also investigating whether repeated doses of IV CR845 over two weeks is safe and effective in reducing the intensity of itching in hemodialysis patients with uremic pruritus (Part B).

Conditions

Interventions

DRUG

Part A: Placebo

Part A: Single i.v. dose of Placebo administered after each dialysis session over a 1 week treatment period (3 times per week)

DRUG

Part A: CR845 0.5 mcg/kg

Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)

DRUG

Part A: CR845 1.0 mcg/kg

Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)

DRUG

Part A: CR845 2.5 mcg/kg

Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)

DRUG

Part B: Placebo

Part B: Single i.v. dose of Placebo administered after each dialysis session over a 2 week treatment period (3 times per week)

DRUG

Part B: CR845 1.0 mcg/kg

Part B: Single i.v. dose of CR845 administered after each dialysis session over a 2 week treatment period (3 times per week)

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Frederique Menzaghi, PhD · Cara Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229929 on ClinicalTrials.gov