Skip to content

Study · Non-randomized trial · n = 8 · 2026

8 results

The pharmacokinetics of a single intravenous dose of difelikefalin in adolescents aged 12 to 17 years on hemodialysis.

Mourani C, Kaur A, Jaoudeh PA, Reynolds B, Morin I, Enoiu M

Pediatric nephrology (Berlin, Germany)19 Oct 2026

PMID42895571 (opens in a new tab)DOI10.1007/s00467-026-07561-7 (opens in a new tab)PepBankPUB-42895571
Publisher pagePubMedAsk about this study
Jump to 8 results

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In adolescents on haemodialysis, one participant developed mild treatment-related headache after difelikefalin.

    In plain wordsIn adolescents on haemodialysis, one participant developed mild headache related to difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableTreatment-related headache
    Study

    n = 8

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    0.5 μg/kg dry body weight · intravenous bolus · single doseAs given in this study (human).

    Source sentences

    Summary
    One participant developed two mild treatment-related AEs (headache and dizziness), but there were no serious AEs or AEs leading to study withdrawal.
    2 context sentences
    Summary · context
    In this multicenter, open-label study, adolescents (12 to 17 years old) received a single difelikefalin dose of 0.5 μg/kg dry body weight at the end of the dialysis.
    Summary · context
    Blood samples were collected over 3 days to assess difelikefalin plasma concentrations, and participants were followed up for adverse events (AEs) for 7-10 days.
  2. 02HumanNon-randomized trialSafety outcome

    In adolescents on haemodialysis, one participant developed mild treatment-related dizziness after difelikefalin.

    In plain wordsIn adolescents on haemodialysis, one participant developed mild dizziness related to difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableTreatment-related dizziness
    Study

    n = 8

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    0.5 μg/kg dry body weight · intravenous bolus · single doseAs given in this study (human).

    Source sentences

    Summary
    One participant developed two mild treatment-related AEs (headache and dizziness), but there were no serious AEs or AEs leading to study withdrawal.
    2 context sentences
    Summary · context
    In this multicenter, open-label study, adolescents (12 to 17 years old) received a single difelikefalin dose of 0.5 μg/kg dry body weight at the end of the dialysis.
    Summary · context
    Blood samples were collected over 3 days to assess difelikefalin plasma concentrations, and participants were followed up for adverse events (AEs) for 7-10 days.
  3. 03HumanNon-randomized trialSafety outcome

    In adolescents on haemodialysis receiving difelikefalin, no serious adverse events occurred.

    In plain wordsIn adolescents on haemodialysis receiving difelikefalin, no serious adverse events occurred.

    Peptide
    Difelikefalin
    Outcome
    Not applicableSerious adverse events
    Study

    n = 8

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 μg/kg dry body weight · intravenous bolus · single doseAs given in this study (human).

    Source sentences

    Summary
    One participant developed two mild treatment-related AEs (headache and dizziness), but there were no serious AEs or AEs leading to study withdrawal.
    2 context sentences
    Summary · context
    In this multicenter, open-label study, adolescents (12 to 17 years old) received a single difelikefalin dose of 0.5 μg/kg dry body weight at the end of the dialysis.
    Summary · context
    Blood samples were collected over 3 days to assess difelikefalin plasma concentrations, and participants were followed up for adverse events (AEs) for 7-10 days.
  4. 04HumanNon-randomized trialSafety outcome

    In adolescents on haemodialysis receiving difelikefalin, no adverse events led to study withdrawal.

    In plain wordsIn adolescents on haemodialysis receiving difelikefalin, no participant withdrew because of adverse events.

    Peptide
    Difelikefalin
    Outcome
    Not applicableAdverse events leading to withdrawal
    Study

    n = 8

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 μg/kg dry body weight · intravenous bolus · single doseAs given in this study (human).

    Source sentences

    Summary
    One participant developed two mild treatment-related AEs (headache and dizziness), but there were no serious AEs or AEs leading to study withdrawal.
    2 context sentences
    Summary · context
    In this multicenter, open-label study, adolescents (12 to 17 years old) received a single difelikefalin dose of 0.5 μg/kg dry body weight at the end of the dialysis.
    Summary · context
    Blood samples were collected over 3 days to assess difelikefalin plasma concentrations, and participants were followed up for adverse events (AEs) for 7-10 days.
  5. 05HumanNon-randomized trialPharmacokinetics

    In adolescents on haemodialysis, single-dose difelikefalin mean maximum plasma concentration was 6.03 ng/mL with standard deviation 1.81.

    In plain wordsIn adolescents on haemodialysis, difelikefalin reached the reported maximum blood concentration after one dose.

    Peptide
    Difelikefalin
    Outcome
    Not applicableMaximum plasma concentration
    Study

    n = 7

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 μg/kg dry body weight · intravenous bolus · single doseAs given in this study (human).

    Measurements

    Mean Cmax
    6.03 ng/mL
    reported result
    Cmax SD
    1.81 ng/mL
    reported result

    Source sentences

    Summary
    Mean (standard deviation) Cmax, AUC0-48 h, and AUCinf were 6.03 (1.81) ng/mL, 63.4 (17.4) h ng/mL, and 72.5 (23.7) h ng/mL, respectively.
    2 context sentences
    Summary · context
    In this multicenter, open-label study, adolescents (12 to 17 years old) received a single difelikefalin dose of 0.5 μg/kg dry body weight at the end of the dialysis.
    Summary · context
    Blood samples were collected over 3 days to assess difelikefalin plasma concentrations, and participants were followed up for adverse events (AEs) for 7-10 days.
  6. 06HumanNon-randomized trialPharmacokinetics

    In adolescents on haemodialysis, difelikefalin mean AUC from zero to 48 hours was 63.4 h ng/mL with standard deviation 17.4.

    In plain wordsIn adolescents on haemodialysis, difelikefalin exposure over the measured period reached the reported value.

    Peptide
    Difelikefalin
    Outcome
    Not applicableAUC from zero to 48 hours
    Study

    n = 7

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 μg/kg dry body weight · intravenous bolus · single doseAs given in this study (human).

    Measurements

    Mean AUC0-48
    63.4 h ng/mL
    reported result
    AUC0-48 SD
    17.4 h ng/mL
    reported result

    Source sentences

    Summary
    Mean (standard deviation) Cmax, AUC0-48 h, and AUCinf were 6.03 (1.81) ng/mL, 63.4 (17.4) h ng/mL, and 72.5 (23.7) h ng/mL, respectively.
    2 context sentences
    Summary · context
    In this multicenter, open-label study, adolescents (12 to 17 years old) received a single difelikefalin dose of 0.5 μg/kg dry body weight at the end of the dialysis.
    Summary · context
    Blood samples were collected over 3 days to assess difelikefalin plasma concentrations, and participants were followed up for adverse events (AEs) for 7-10 days.
  7. 07HumanNon-randomized trialPharmacokinetics

    In adolescents on haemodialysis, difelikefalin mean AUC extrapolated to infinity was 72.5 h ng/mL with standard deviation 23.7.

    In plain wordsIn adolescents on haemodialysis, estimated total difelikefalin exposure reached the reported value.

    Peptide
    Difelikefalin
    Outcome
    Not applicableAUC extrapolated to infinity
    Study

    n = 7

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 μg/kg dry body weight · intravenous bolus · single doseAs given in this study (human).

    Measurements

    Mean AUCinf
    72.5 h ng/mL
    reported result
    AUCinf SD
    23.7 h ng/mL
    reported result

    Source sentences

    Summary
    Mean (standard deviation) Cmax, AUC0-48 h, and AUCinf were 6.03 (1.81) ng/mL, 63.4 (17.4) h ng/mL, and 72.5 (23.7) h ng/mL, respectively.
    2 context sentences
    Summary · context
    In this multicenter, open-label study, adolescents (12 to 17 years old) received a single difelikefalin dose of 0.5 μg/kg dry body weight at the end of the dialysis.
    Summary · context
    Blood samples were collected over 3 days to assess difelikefalin plasma concentrations, and participants were followed up for adverse events (AEs) for 7-10 days.
  8. 08HumanNon-randomized trialPharmacokinetics

    In adolescents on haemodialysis, systemic difelikefalin exposure was comparable to prior adult data.

    In plain wordsIn adolescents on haemodialysis, difelikefalin exposure was comparable to previous adult results.

    Peptide
    Difelikefalin
    Outcome
    Not applicableSystemic exposure versus adult data
    Study

    n = 7

    Comparator
    Adults on haemodialysis in a previous study
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 μg/kg dry body weight · intravenous bolus · single doseAs given in this study (human).

    Source sentences

    Summary
    Systemic exposure was comparable between adolescents and adults.
    3 context sentences
    Summary · context
    A prespecified numerical comparison of these parameters was conducted against data from a previous study in adults on hemodialysis (NCT02229929).
    Summary · context
    In this multicenter, open-label study, adolescents (12 to 17 years old) received a single difelikefalin dose of 0.5 μg/kg dry body weight at the end of the dialysis.
    Summary · context
    Blood samples were collected over 3 days to assess difelikefalin plasma concentrations, and participants were followed up for adverse events (AEs) for 7-10 days.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT02229929

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

Cara Therapeutics, Inc.n = 89Jul 2014 to Jul 2015

Pruritus · Uremic Pruritus

Trial pageClinicalTrials.govUpdated 10 Aug 2016

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

PepBank is a research reference. Talk to a doctor before you use any peptide.