A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

NCT03617536 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CR845 210301
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 60

Brief Summary

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).

Conditions

Chronic Kidney Diseases; Pruritus

Keywords

difelikefalin; CR845; Pruritus; Chronic Itch; Itch; Itching; uremic pruritus; CKD; CKD-aP; CKD-associated pruritus; Chronic Kidney Disease; Kidney dysfunction; Generalized pruritus; Hemodialysis; Dialysis; ESRD (end stage renal disease); Kidney failure, chronic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12

  Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". Higher scores meant worse itch intensity.

  Baseline, Week 12

Secondary Outcomes (3)

• Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12

  Baseline, Week 12

• Change From Baseline in 5-D Itch Scale Score at the End of Week 12

  Baseline, Week 12

• Reduction of Itch Intensity as Assessed by the Proportion of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12

  Week 12

Study Arms (4)

CR845 0.25 mg Oral Tablet

EXPERIMENTAL

Oral CR845 0.25 mg to be taken orally once daily for 12 weeks

Drug: CR845 0.25 mg Oral Tablet

CR845 0.5 mg Oral Tablet

EXPERIMENTAL

Oral CR845 0.5 mg to be taken orally once daily for 12 weeks

Drug: CR845 0.5 mg Oral Tablet

CR845 1 mg Oral Tablet

EXPERIMENTAL

Oral CR845 1 mg to be taken orally once daily for 12 weeks

Drug: CR845 1 mg Oral Tablet

Placebo Oral Tablet

PLACEBO COMPARATOR

Oral Placebo to be taken orally once daily

Drug: Placebo Oral Tablet

Interventions

CR845 0.25 mg Oral Tablet DRUG

CR845 0.25 mg medication taken orally 1 time/day

Also known as: Difelikefalin

CR845 0.25 mg Oral Tablet

CR845 0.5 mg Oral Tablet DRUG

CR845 0.5 mg medication taken orally 1 time/day

Also known as: Difelikefalin

CR845 0.5 mg Oral Tablet

CR845 1 mg Oral Tablet DRUG

CR845 1 mg medication taken orally 1 time/day

Also known as: Difelikefalin

CR845 1 mg Oral Tablet

Placebo Oral Tablet DRUG

Placebo tablet taken orally 1 time/day

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated glomerular filtration rate (GFR) ≥30 and \<60 mL/min/1.73 m2 or severe renal impairment with estimated GFR \<30 mL/min/1.73 m2).
• For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening;
• Prior to randomization:
• Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period;
• Has a mean baseline Worst Itching Intensity NRS score ≥5, defined as the average of all non-missing scores reported from the start of the 7-day Run-in Period.

You may not qualify if:

• A patient will be excluded from the study if any of the following criteria are met:
• Patients not currently on dialysis who are likely to initiate routine dialysis during study participation;
• Scheduled to receive a kidney transplant during the study;
• New or change of treatment received for itch including antihistamines and corticosteroids (oral, intravenous \[IV\], or topical) within 14 days prior to screening;
• Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study;
• Received ultraviolet B treatment within 30 days prior to the start of screening or anticipates receiving such treatment during the study;
• Participated in a previous clinical study with CR845.

Sponsors & Collaborators

• Cara Therapeutics, Inc.: lead

Study Sites (60)

Cara Therapeutics Study Site

Birmingham, Alabama, 35233, United States

Location

Cara Therapeutics Study Site

Florence, Alabama, 35630, United States

Location

Cara Therapeutics Study Site

Phoenix, Arizona, 85016, United States

Location

Cara Therapeutics Study Site

Prescott, Arizona, 86401, United States

Location

Cara Therapeutics Study Site

Sun City, Arizona, 85351, United States

Location

Cara Therapeutics Study Site

Harrisburg, Arkansas, 72432, United States

Location

Cara Therapeutics Study Site

Bakersfield, California, 93309, United States

Location

Cara Therapeutics Study Site 2

Bakersfield, California, 99309, United States

Location

Cara Therapeutics Study Site

Canyon Country, California, 91351, United States

Location

Cara Therapeutics Study Site

Escondido, California, 92025, United States

Location

Cara Therapeutics Study Site

Lomita, California, 90717, United States

Location

Cara Therapeutics Study Site

Northridge, California, 91324, United States

Location

Cara Therapeutics Study Site

Riverside, California, 92505, United States

Location

Cara Therapeutics Study Site

Sacramento, California, 95831, United States

Location

Cara Therapeutics Study Site

Whittier, California, 90602, United States

Location

Cara Therapeutics Study Site

Denver, Colorado, 80230, United States

Location

Cara Therapeutics Study Site

Washington D.C., District of Columbia, 20037, United States

Location

Cara Therapeutics Study Site

Edgewater, Florida, 32132, United States

Location

Cara Therapeutics Study Site

Hialeah, Florida, 33016, United States

Location

Cara Therapeutics Study Site

Hollywood, Florida, 33024, United States

Location

Cara Therapeutics Study Site

Lake Worth, Florida, 33467, United States

Location

Cara Therapeutics Study Site 1

Miami, Florida, 33125, United States

Location

Cara Therapeutics Study Site 2

Miami, Florida, 33155, United States

Location

Cara Therapeutics Study Site

Ocala, Florida, 34471, United States

Location

Cara Therapeutics Study Site

Orlando, Florida, 32810, United States

Location

Cara Therapeutics Study Site

Tampa, Florida, 33614, United States

Location

Cara Therapeutics Study Site

Temple Terrace, Florida, 33637, United States

Location

Cara Therapeutics Study Site

Augusta, Georgia, 30909, United States

Location

Cara Therapeutics Study Site

Sandy Springs, Georgia, 30328, United States

Location

Cara Therapeutics Study Site

Crystal Lake, Illinois, 60012, United States

Location

Cara Therapeutics Study Site

Evanston, Illinois, 60201, United States

Location

Cara Therapeutics Study Site

Iowa City, Iowa, 52242, United States

Location

Cara Therapeutics Study Site

Metairie, Louisiana, 70006, United States

Location

Cara Therapeutics Study Site

New Orleans, Louisiana, 70115, United States

Location

Cara Therapeutics Study Site

Zachary, Louisiana, 70791, United States

Location

Cara Therapeutics Study Site

Baltimore, Maryland, 21287, United States

Location

Cara Therapeutics Study Site

Takoma Park, Maryland, 20912, United States

Location

Cara Therapeutics Study Site

Flint, Michigan, 48503, United States

Location

Cara Therapeutics Study Site 2

Flint, Michigan, 48532, United States

Location

Cara Therapeutics Study Site

Roseville, Michigan, 48066, United States

Location

Cara Therapeutics Study Site

Saint Clair, Michigan, 48081, United States

Location

Cara Therapeutics Study Site

Kansas City, Missouri, 64111, United States

Location

Cara Therapeutics Study Site

Brooklyn, New York, 11229, United States

Location

Cara Therapeutics Study Site

Mineola, New York, 11501, United States

Location

Cara Therapeutics Study Site

Rocky Mount, North Carolina, 27804, United States

Location

Cara Therapeutics Study Site

Columbus, Ohio, 43215, United States

Location

Cara Therapeutics Study Site

Norman, Oklahoma, 73071, United States

Location

Cara Therapeutics Study Site

Camp Hill, Pennsylvania, 17011, United States

Location

Cara Therapeutics Study Site

Providence, Rhode Island, 02903, United States

Location

Cara Therapeutics Study Site

Warwick, Rhode Island, 02886, United States

Location

Cara Therapeutics Study Site

Greenville, South Carolina, 29605, United States

Location

Cara Therapeutics Study Site

Rapid City, South Dakota, 57702, United States

Location

Cara Therapeutics Study Site

Corsicana, Texas, 75110, United States

Location

Cara Therapeutics Study Site

Gonzales, Texas, 78629, United States

Location

Cara Therapeutics Study Site

Houston, Texas, 77074, United States

Location

Cara Therapeutics Study Site

Houston, Texas, 77081, United States

Location

Cara Therapeutics Study Site

Plano, Texas, 75093, United States

Location

Cara Therapeutics Study Site

San Antonio, Texas, 78207, United States

Location

Cara Therapeutics Study Site

San Antonio, Texas, 78224, United States

Location

Cara Therapeutics Study Site

Alexandria, Virginia, 22304, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Pruritus; Kidney Failure, Chronic

Interventions

Tablets; difelikefalin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Cara Therapeutics

clinicaltrials.gov@caratherapeutics.com

203-406-3700

Study Officials

• Frédérique Menzaghi, PhD

  Cara Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: CR845 will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose. CR845 tablets will be provided at doses of 0.25, 0.5, and 1 mg.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo controlled study

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 6, 2018
• Study Start: July 5, 2018
• Primary Completion: October 24, 2019
• Study Completion: November 14, 2019
• Last Updated: January 24, 2024
• Results First Posted: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (60)