Prevention of Akute Kidney Injury, Hearttransplant, ANP | NCT02665377

Studies
Prevention of Akute Kidney Injury, Hearttransplant, ANP

NCT02665377

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Feb 9, 2022Actual

Enrollment

86Actual

Phase

Phase 3

Conditions

Acute Kidney Injury

Interventions

ANP
Placebo

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2016Actual

Primary Completion Date

Jan 8, 2022Actual

Completion Date

Jan 8, 2022Actual

First Submitted Date

Jan 22, 2016

First Submission Date that Met QC Criteria

Jan 22, 2016

First Posted Date

Jan 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2022

Last Update Posted Date

Feb 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ANP	Drug		ANP
Placebo	Drug

Measure	Description	Time Frame
GFR 4-5 days after Htx		4-5 days

Measure	Description	Time Frame
GFR 1 year after Htx		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sven-Erik Ricksten, Prof	Sahlgrenska universitetssjukhuset	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska sjukhuset		Gothenburg		413 45	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39878152	Derived	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.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D045265	Natriuretic Peptides
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists