NCT02665377

Brief Summary

Prospective, blinded, placebo-controlled trial. Patients: Adult patients (\>18 years of age) undergoing de novo Htx, with a preoperative GFR \> 30ml/min, not receiving an ABO-incompatible organ with an ischemia time of \> 6 hours. A donor age \> 70 years is an exclusion criteria. Intervention: Infusion of h-ANP fore five days, starting at the induction of anesthesia. Outcome: Kidney function, evaluated with serum creatinine day 1-7 and kidney clearance, 4-5 Days after Htx plus after 3 and 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

September 25, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2022

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

5.3 years

First QC Date

January 22, 2016

Last Update Submit

February 8, 2022

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • GFR 4-5 days after Htx

    4-5 days

Secondary Outcomes (1)

  • GFR 1 year after Htx

    1 year

Study Arms (2)

ANP

ACTIVE COMPARATOR

Infusion of h-ANP at dose of 50ng/kg/min fore 5 days, starting at the induction of anesthesia.

Drug: ANP

Placebo

PLACEBO COMPARATOR

Infusion of NaCl at the same volyme as for ANP for 5 days.

Drug: Placebo

Interventions

ANPDRUG
ANP
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • De novo Htx.
  • Preoperative GFR \> 30ml/min/1,73m2.
  • \>18 years old.
  • Written consent.

You may not qualify if:

  • Multi organ transplantation or previous heart transplant.
  • ECMO
  • Donor age \> 70 years.
  • Dialysis.
  • ABO-incompatible organ.
  • Donor heart ischemia time \> 6 tim.
  • Known kidney disease.
  • Other planed study within 2 mounth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska sjukhuset

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

  • Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

    PMID: 39878152DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Atrial Natriuretic Factor

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Sven-Erik Ricksten, Prof

    Sahlgrenska universitetssjukhuset

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

September 25, 2016

Primary Completion

January 8, 2022

Study Completion

January 8, 2022

Last Updated

February 9, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)