Cardiorenal Effecs of Losartan in Kidney Transplant Recip... | NCT05243446

Studies
Cardiorenal Effecs of Losartan in Kidney Transplant Recipients

NCT05243446

Sponsor

Medical University of Gdansk

Status

Unknown status

Last Update Posted

Feb 17, 2022Actual

Enrollment

740Estimated

Phase

Not provided

Conditions

Renal Transplant Failure
Cardiovascular Complication

Interventions

Losartan

Countries

Poland

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jan 24, 2022

First Submission Date that Met QC Criteria

Feb 3, 2022

First Posted Date

Feb 17, 2022Actual

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 3, 2022

Last Update Posted Date

Feb 17, 2022Actual

Name	Class
Medical University of Warsaw	OTHER
Pomeranian Medical University Szczecin	OTHER
Jagiellonian University	OTHER
Medical University of Bialystok

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

The influence of Losartan to cardiovascular and renal outcomes in patients after renal transplatation.

Detailed Description

The benefits of cardio and nephroprotective properties of treatment with drugs blocking the renin angiotensin aldosterone system in the general population has already been shown. There are no data on the cardiac and renal effects of this type of treatment in patients after renal transplantation.

Therefore, the observational, case-control study was designed in a population of kidney transplant recipients.

The study group consists of patients treated with antihypertensive drugs including Losartan at a minimum dose of 50mg.

The control group consists of patients treated with antihypertensive drugs, without the renin angiotensin aldosterone system blockade.

Blood pressure will be controlled in accordance with the current recommendations.

The primary aim of this study is to determine whether, in renal transplant recipients with hypertension, losartan, angiotensin II receptor antagonist improves cardiovascular and graft outcome i.e. reduces incidence of cardiovascular complications and slows progression of graft insufficiency. Secondary objective is to determine whether losartan 1. delays the occurrence of cardiovascular complications, 2. slows progression of graft insufficiency, 3. is the safe drug in renal transplant recipients, 4. decrease albuminuria and other surrogate markers of graft injury or cardiovascular involvement.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

740Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Hypotensive treatment including Losartan	Drug: Losartan
Control group		Hypotensive treatment without renin-angiotensin-aldosteron system blockers.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Losartan	Drug	losartan treatment	Study group	Lozap, Lorista, Xartan, Losacor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of composite primary endpoint:	Cardiovascular (CV) death and Resuscitated sudden death and Non-fatal myocardial infarction (MI) and Non-fatal stroke and Unplanned hospitalization for heart failure or unstable angina and Onset of end-stage renal disease (ESRD) and Doubling of baseline serum creatinine concentration, sustained for at least one month.	Up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of cardiovascular complications	Cardiovascular (CV) death and Resuscitated sudden death and Non-fatal myocardial infarction (MI) and Non-fatal stroke and Unplanned hospitalization for heart failure or unstable angina	Up to 5 years
Occurrence of renal complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

740 patients, either sex, either non-diabetic or diabetic who underwent the kidney transplantation and who:

Are at least three months post-transplantation
Have hypertension.
Have an estimated glomerular filtration rate greater than or equal to 30 ml/min/1.73 m2

Exclusion Criteria:

Pregnant or the possibility of becoming so and breast feeding.
Angioedema from an Angiotensin Converting Enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) in the history.
Serum potassium greater than 5.5 mmol/l on two or more occasions in the preceding three months.
Graft artery stenosis (i.e. psv of more than 200 cm/s in doppler usg)
Left ventricular dysfunction that requires an ACE inhibitor or an ARB
New immunosuppressive agent was started or previous immunosuppressant stopped in the three months prior to study entry or plan to switch immunosuppressive agents within next three months.
Currently on four or more blood pressure pills and have an average blood pressure over three visits greater than 150/100.
Currently on an ACE-inhibitor or an ARB or treatment with an ACE inhibitor or ARB after kidney transplantation lasted more than 3 months.
Had an acute coronary syndrome, episode of malignant hypertension, stroke or transient ischaemic attack in the three months prior to study entry.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients after renal transplantation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leszek Tylicki, professor	Contact	48583492505
Zbigniew Heleniak	Contact	48583492505		zth1@gumed.edu.pl

Overall Officials

Name	Affiliation	Role
Leszek Tylicki, professor	Medical University of Gdansk	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University	Recruiting	Gdansk		80-952	Poland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000419	Albuminuria
D002318	Cardiovascular Diseases

ID	Term
D011507	Proteinuria
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic