Renal Transplant FailureCELARTNCT05243446
Cardiorenal Effecs of Losartan in Kidney Transplant Recipients
An observational study of Renal Transplant Failure and Cardiovascular Complication, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The influence of Losartan to cardiovascular and renal outcomes in patients after renal transplatation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplant Failure, Cardiovascular Complication
- What is being tested?
- Losartan
- How many people
- 740 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2015to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after renal transplantation.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Leszek Tylicki, professor contact
Poland1 site, 1 recruiting
- Recruiting
Medical University
Gdansk, 80-952
Leszek Tylicki, professor, 48583492505, leszek.tylicki@gumed.edu.pl
Zbigniew Heleniak, 48583492505, zth1@gumed.edu.pl
About this study
The influence of Losartan to cardiovascular and renal outcomes in patients after renal transplatation.
Read the 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.
- Being tested
- Losartan
- Keywords
- angiotensin receptor blocker, kidney transplant recipients, albuminuria, cardiovascular disease, nephroprotection
- Medical subject headings
- Albuminuria, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Lozap, Lorista, Xartan, Losacor
losartan treatment
| Study group | Role | What they receive |
|---|---|---|
| Study group | Hypotensive treatment including Losartan Receives: Drug: Losartan | |
| Control group | Hypotensive treatment without renin-angiotensin-aldosteron system blockers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (6)
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
Measured: Up to 5 years
Occurrence of renal complications
ESRD or doubling of baseline serum creatinine
Measured: Up to 5 years
Decline in estimated glomerular filtration rate (eGFR)
Difference in degree of eGFR reduction
Measured: Up to 5 years
Urine albumine concentration
Difference in albuminuria in the measurements available for each patient
Measured: after 6 months
N-acetyl-β-D-glucosaminidase (NAG) urine excretion
Difference in urine NAF in the measurements available for each patient
Measured: after 6 months
15-F2t-isoprostanes (isoprostanes) urine excretion
differences in 15-F2t-isoprostanes (isoprostanes) urine excretion in the measurements available for each patient
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study startSep 2015
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant FailureStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw, Pomeranian Medical University Szczecin, Jagiellonian University, Medical University of Bialystok, Nicolaus Copernicus University, Medical University of Silesia, Poznan Regional Hospital, Wroclaw Medical University
- Responsible party
- Principal investigator, Leszek Tylicki, Medical University of Gdansk
- Investigators
- Leszek Tylicki, professor, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243446
- Sponsor's protocol ID
- ST-4/CELART
- Acronym
- CELART
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorenal Effecs of Losartan in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT05243446
- Acronym / sponsor ID
- CELART / ST-4/CELART
- Keywords
- angiotensin receptor blocker, kidney transplant recipients, albuminuria, cardiovascular disease, nephroprotection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- Medical University of Warsaw, Pomeranian Medical University Szczecin, Jagiellonian University, Medical University of Bialystok, Nicolaus Copernicus University, Medical University of Silesia, Poznan Regional Hospital, Wroclaw Medical University
- Study start
- Sep 2015
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: LosartanHypotensive treatment including Losartan |
| Control group | – | –Hypotensive treatment without renin-angiotensin-aldosteron system blockers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after renal transplantation.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LosartanAlso: Lozap, Lorista, Xartan, Losacorlosartan treatment | Drug | Study group |
Primary outcome
Occurrence of composite primary endpoint:
Time frame: Up to 5 years
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.
6 secondary outcomes
Occurrence of cardiovascular complications
Time frame: Up to 5 years
Occurrence of renal complications
Time frame: Up to 5 years
Decline in estimated glomerular filtration rate (eGFR)
Time frame: Up to 5 years
Urine albumine concentration
Time frame: after 6 months
N-acetyl-β-D-glucosaminidase (NAG) urine excretion
Time frame: after 6 months
15-F2t-isoprostanes (isoprostanes) urine excretion
Time frame: after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leszek Tylicki, professor contact
Leszek Tylicki, professor principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant Failure and Cardiovascular Complication, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leszek Tylicki, professor (48583492505), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of composite primary endpoint: (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.