CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-2)

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Cara Therapeutics

Status and phase

Completed
Phase 3

Conditions

Uremic Pruritus

Treatments

Drug: CR845 0.5 mcg/kg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03636269
CR845-CLIN3103

Details and patient eligibility

About

This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.

Full description

Double-blind Phase: The Double-blind Phase of the study will consist of a Screening Visit, a 7-day Run-in Period, and a 12-week Double-blind Treatment Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility. Open-label Extension Phase: Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will have the option to receive open label CR845 for an additional 52 weeks. The last dose of open-label study drug will be administered at the last dialysis visit on Week 52, or Early Termination. Follow-up Period: A final safety Follow up Visit will be conducted 7-10 days after the End of Treatment/Early Termination Visit.

Enrollment

473 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

To be eligible for inclusion into the Double-blind Phase of the study, a patient must meet the following criteria:

  • Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening;
  • Has at least 2 single-pool Kt/V measurements ≥1.2, or at least 2 urea reduction ratio measurements ≥65%, or 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis days during the 3 months period prior to screening;

Prior to randomization:

  • Has completed Worst Itching Intensity NRS worksheets up to 8 days prior to 1st dose;
  • Has a mean baseline Worst Itching Intensity NRS indicative of moderate to severe uremic pruritus.

To be eligible for inclusion into the Open-label Extension Phase of the study, each patient will have to fulfill the additional key following criteria at the time of entry into the Open-label Extension Phase:

  • Has received at least 30 doses of the planned 36 doses of study drug during the Double-blind Phase of this study;
  • Continues to meet inclusion criteria.

Key Exclusion Criteria:

A patient will be excluded from the Double-blind Phase of the study if any of the following criteria are met:

  • Known noncompliance with dialysis treatment that in the opinion of the investigator would impede completion or validity of the study;
  • Scheduled to receive a kidney transplant during the study;
  • New or change of treatment received for itch including antihistamines and corticosteroids (oral, 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;
  • Has pruritus only during the dialysis session (by patient report);
  • Is receiving ongoing ultraviolet B and anticipates receiving such treatment during the study;
  • Participated in a previous clinical study with CR845.

A patient will be excluded from the Open-label Extension Phase of the study if any of the additional key following criteria are met at the time of entry into the Open-label Extension Phase:

  • Completed the Double-blind Phase of this study but exhibited adverse events during the course of the Treatment Period that may preclude continued exposure to the study drug;
  • Was noncompliant with protocol procedures during the Double-blind Phase of this study which is indicative of an inability to follow protocol procedures.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

473 participants in 2 patient groups, including a placebo group

CR845 0.5mcg/kg
Active Comparator group
Description:
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Treatment:
Drug: CR845 0.5 mcg/kg
Placebo
Placebo Comparator group
Description:
IV Placebo administered after each dialysis session (3 times/week)
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

93

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Data sourced from clinicaltrials.gov

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