Primary outcomeCount of participants· Up to Follow-Up Visit (Week 13-14)
Number of Participants With AEs.
| Group | Value (Participants) |
|---|---|
| CR845 0.5mcg/kg | 143 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataCR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCTNCT03998163 (opens ClinicalTrials.gov in a new tab)Other idCR845-CLIN3105
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 222 participants (actual)
- Sponsor
- Cara Therapeutics, Inc. · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
4 countries
United States, Czechia, Hungary, Poland
- Start
- 6 May 2019
- Primary completion
- 26 Feb 2020
- Completion
- 6 Mar 2020
- First posted
- 26 Jun 2019
- Last update posted
- 15 Oct 2021
- Conditions
- Uremic Pruritus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201920202021
- Ph 3
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCT039981636 May 2019 to 6 Mar 2020
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
Interventions
- CR845 0.5 mcg/kgDrug
Arms1
Experimental
CR845 0.5mcg/kg
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants With AEs.
Time frame · Up to Follow-Up Visit (Week 13-14)
Registry description
Assessed by monitoring of adverse events.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| CR845 0.5mcg/kgIV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week | 3 / 222 | 45 / 222 | 11 / 222 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies4
Studies that cite this trial.
Studies with results
4 studies on this page
Indexing hint: Randomized controlled trial · 2024
1 result
Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis.
Weiner et al. 2024Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Associationcited by 13
PMID 37968132PMC11210984DOI 10.1093/ndt/gfad245PUB-37968132
CC BY1 result
Indexing hint: Clinical trial · 2024
7 results
Impact of Difelikefalin on the Health-Related Quality of Life of Haemodialysis Patients with Moderate-To-Severe Chronic Kidney Disease-Associated Pruritus: A Single-Arm Intervention Trial.
Fotheringham et al. 2024The patientcited by 12
PMID 38196014PMC10894140DOI 10.1007/s40271-023-00668-1PUB-38196014
Free to read · publisher termsCC BY-NC7 results
PubMed tag: none · 2022
14 results
Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program.
Fishbane et al. 2022Kidney medicinecited by 38
PMID 36039153PMC9418597DOI 10.1016/j.xkme.2022.100513PUB-36039153
Free to read · publisher termsCC BY-NC-ND14 results
PubMed tag: none · 2022
11 results
Safety and Effectiveness of Difelikefalin in Patients With Moderate-to-Severe Pruritus Undergoing Hemodialysis: An Open-Label, Multicenter Study.
Weiner et al. 2022Kidney medicinecited by 17
PMID 36185706PMC9516453DOI 10.1016/j.xkme.2022.100542PUB-36185706
Free to read · publisher termsCC BY-NC-ND11 results
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedFishbane SN, Block GA, Evenepoel P, Budden J, Morin I, Menzaghi F, Wen W, Lerma EV. Pruritus Severity and Serum Phosphate in CKD: A Post Hoc Analysis of Difelikefalin Studies. Kidney360. 2024 Sep 1;5(9):1270-1280. doi: 10.34067/KID.0000000000000520. Epub 2024 Jul 22. PMID 39037824
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Key Inclusion Criteria:
To be eligible for inclusion into 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 Treatment:
* Has completed at least 3 Worst Itching Intensity NRS questionnaires from the start of the Run-in Period up to and including the pre-dose assessment on Day 1;
Key Exclusion Criteria:
A patient will be excluded from 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;
* New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening;
* Received another investigational drug within 30 days or five half-lives (whichever is longer) prior to the start of dosing or is planning to participate in another interventional clinical study while enrolled in this study;
* Has pruritus only during the dialysis session (by patient report);
* Is receiving ongoing ultraviolet B treatment and/or anticipates receiving such treatment during the study;
* Participated in a previous clinical study with CR845.
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