Kidney Transplant RecipientsKT-LIFESTYLENCT06806670
Exercise and Diet Effects in Reducing Cardiovascular Risk in Kidney Transplant Recipients
A study testing lifestyle intervention in people with Kidney Transplant Recipients, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this clinical trial is to assess whether, over an observation period of 3 years, there is a reduction in cardiovascular risk, and the extent of this reduction, in a group of adult kidney transplant patients undergoing tailored exercise combined with dietary counselling compared to a group of patients… Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2025to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stabilised male and female kidney transplant patients (assessment by the referring transplant centre)
- Minimum age, 30 years;
- Maximum age, 69 years;
- Period since transplantation: from 6 months (subject to clinical stability being achieved) to 10 years;
- Organ function: eGFR (CKD-EPI formula) ≥ 30 mL/min/1.73m ;2
- Obtaining informed consent;
Who cannot join
- Patients unable to follow the prescription,
- Recent acute cardiovascular event (< 2 months),
- Unstable angina,
- Hyperkinetic/hypokinetic arrhythmias not controlled by therapy, and with signs of haemodynamic impairment,
- Severe aortic stenosis,
- Heart failure NYHA class III-IV, FE < 40%,
Show all 12Show fewer
- Acute illnesses that limit physical activity,
- Severe hypertension (basal BP ≥200/110 mm Hg),
- Neuro-musculo-skeletal pathologies that may be aggravated by exercise,
- Patients unwilling to change lifestyle;
- Any form of substance abuse, psychiatric disorder or condition that, according to the investigator, can complicate communication between doctor and patient;
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valentina Totti, PhD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138
Giuseppe Tarantino, MD, 0512144912, giuseppe.tarantino@aosp.bo.it
Valentina Totti, PhD, valentina.totti@iss.it
About this study
Official title: Effects of Exercise and Dietary Counselling in Reducing the Cardiovascular Risk Score in Kidney Transplant Patients: KT- LIFESTYLE Study
The goal of this clinical trial is to assess whether, over an observation period of 3 years, there is a reduction in cardiovascular risk, and the extent of this reduction, in a group of adult kidney transplant patients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care'.
Read the detailed description
The main questions it aims to answer are:
- Prescribed exercise and dietary counselling could reduce of at least 1% in the cardiovascular risk score (by Framingham score) and cardiovascular biomarkers in kidney transplant recipients?
- How much can a lifestyle intervention affect kidney function, quality of life and the gut microbiota in this patient population?
Researchers will compare kidney transplant recipients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care' to see if there is a reduction in cardiovascular risk, BMI, inflammatory markers, improve of gut microbiota and perception of quality of life. In addition, a number of hospital admissions for important clinical events, the number of fatal and non-fatal cardiovascular events (MACE), and mortality from all causes will be assessed in the long term.
Participants will enroll from the Nephrology, Dialysis and Transplant Units and randomize in intervantion group (A) or control (B).
In group A/intervention, a tailored exercise programme combined with specific dietary counselling will be prescribed, in group B/control, generic advice on healthy lifestyles will be given (standard of care) without specific prescription.
In all patients, quality of life, gut microbiota, inflammatory and cardiovascular biomarkers (Framingham score, BNP, etc.), lipid profile and renal function over time will be assessed.
- Conditions
- Kidney Transplant Recipients
- Being tested
- lifestyle intervention
- Keywords
- exercise, diet, cardiovascular risk, kidney transplant recipients, gut microbiota, lifestyle
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle interventionBehavioural
exercise and dietary counselling
| Study group | Role | What they receive |
|---|---|---|
| Group A, lifestyle intervention | Experimental | lifestyle intervention Receives: Behavioral: lifestyle intervention |
| Group B | No intervention | standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk reduction
reduction of at least 1% in the cardiovascular risk score - Framingham score - over the observation time. This score estimates the risk of developing a cardiovascular event over a 10-year period and is calculated in relation to the outcome from the following identifiable variables in normal clinical practice:
- Sex
- Age
- Systolic pressure value
- Treatment for hypertension (yes/no)
- Smoker (yes/no)
- Diabetes (yes/no)
- HDL value
- Total cholesterol value
Measured: From enrollment to the end of the treatment (3 years)
Secondary outcomes (7)
Renal function
The trend of renal function assess by eGFR using the CKD-EPI formula
Measured: From enrollment to the end of the treatment (3 years)
Gut microbiota analysis
The relative abundances of the main intestinal bacterial groups and hence the effect of physical exercise on the gut microbiota
Measured: From enrollment to the end of the treatment (3 years)
Inflammatory status
The variation of the inflammatory status (by CRP analysis, IL-6, ferritin, cortisol)
Measured: From enrollment to the end of the treatment (3 years)
Quality of Life (QoL)
The perception of quality of life through the SF12 questionnaire (composite items of physical and mental health)
Measured: From enrollment to the end of the treatment (3 years)
Adherence to the lifestyle intervention
Adherence to dedicated counseling through IPAQ questionnaire to assess physical activity and food frequency questionnaire to assess diet
Measured: From enrollment to the end of the treatment (3 years)
Cost-effectiveness of a healthy lifestyle intervention
number of hospital admissions for major clinical events
Measured: From enrollment to the end of the treatment (3 years)
Cardiovascular biomarkers
the trend of biomarkers related to cardiovascular risk (lipid profile, BNP)
Measured: From enrollment to the end of the treatment (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start7 Jan 2025
- Primary completionJan 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CNT (Centro Nazionale Trapianti), Azienda Unità Sanitaria Locale della Romagna
- Responsible party
- Sponsor
- Investigators
- Giuseppe Tarantino, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806670
- Sponsor's protocol ID
- KT LIFESTYLE
- Other IDs
- RC24000854 - 2790615
- Acronym
- KT-LIFESTYLE
- Status last verified
- Jul 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Padua Netto MV, Bonfim TC, Costa EN, de Lima HV, Netto LC. Cardiovascular risk estimated in renal transplant recipients with the Framingham score. Transplant Proc. 2012 Oct;44(8):2337-40. doi: 10.1016/j.transproceed.2012.07.054.
PubMed 23026587Henry RM, Kostense PJ, Bos G, Dekker JM, Nijpels G, Heine RJ, Bouter LM, Stehouwer CD. Mild renal insufficiency is associated with increased cardiovascular mortality: The Hoorn Study. Kidney Int. 2002 Oct;62(4):1402-7. doi: 10.1111/j.1523-1755.2002.kid571.x.
PubMed 12234312Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Hypertension. 2003 Nov;42(5):1050-65. doi: 10.1161/01.HYP.0000102971.85504.7c. No abstract available.
PubMed 14604997Totti V, Fernhall B, Di Michele R, Todeschini P, La Manna G, Cappuccilli M, Angelini ML, De Fabritiis M, Merni F, Benedetti E, Roi GS, Nanni Costa A, Mosconi G. Longitudinal Analysis of Cardiovascular Risk Factors in Active and Sedentary Kidney Transplant Recipients. Medicina (Kaunas). 2020 Apr 16;56(4):183. doi: 10.3390/medicina56040183.
PubMed 32316125Masiero L, Puoti F, Bellis L, Lombardini L, Totti V, Angelini ML, Spazzoli A, Nanni Costa A, Cardillo M, Sella G, Mosconi G. Physical activity and renal function in the Italian kidney transplant population. Ren Fail. 2020 Nov 10;42(1):1192-1204. doi: 10.1080/0886022X.2020.1847723.
PubMed 33256487Totti V, Tame M, Burra P, Mosconi G, Roi GS, Sella G, Ermolao A, Ferrarese A, Sgarzi S, Savino G, Parodi G, Poggioli G, Ricchiuti A, Di Michele R, Trerotola M, Nanni Costa A. Physical Condition, Glycemia, Liver Function, and Quality of Life in Liver Transplant Recipients After a 12-Month Supervised Exercise Program. Transplant Proc. 2019 Nov;51(9):2952-2957. doi: 10.1016/j.transproceed.2019.03.087. Epub 2019 Oct 10.
PubMed 31607623Roi GS, Mosconi G, Totti V, Angelini ML, Brugin E, Sarto P, Merlo L, Sgarzi S, Stancari M, Todeschini P, La Manna G, Ermolao A, Tripi F, Andreoli L, Sella G, Anedda A, Stefani L, Galanti G, Di Michele R, Merni F, Trerotola M, Storani D, Nanni Costa A. Renal function and physical fitness after 12-mo supervised training in kidney transplant recipients. World J Transplant. 2018 Feb 24;8(1):13-22. doi: 10.5500/wjt.v8.i1.13.
PubMed 29507858Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8.
PubMed 22818941van der Ploeg HP, Bull FC. Invest in physical activity to protect and promote health: the 2020 WHO guidelines on physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):145. doi: 10.1186/s12966-020-01051-1.
PubMed 33239047Markell MS, Armenti V, Danovitch G, Sumrani N. Hyperlipidemia and glucose intolerance in the post-renal transplant patient. J Am Soc Nephrol. 1994 Feb;4(8 Suppl):S37-47. doi: 10.1681/ASN.V48s37.
PubMed 8193294Painter P. Exercise following organ transplantation: A critical part of the routine post transplant care. Ann Transplant. 2005;10(4):28-30.
PubMed 17037085Seoane-Pillado MT, Pita-Fernandez S, Valdes-Canedo F, Seijo-Bestilleiro R, Pertega-Diaz S, Fernandez-Rivera C, Alonso-Hernandez A, Gonzalez-Martin C, Balboa-Barreiro V. Incidence of cardiovascular events and associated risk factors in kidney transplant patients: a competing risks survival analysis. BMC Cardiovasc Disord. 2017 Mar 7;17(1):72. doi: 10.1186/s12872-017-0505-6.
PubMed 28270107Lim WH, Lok C, Kim SJ, Knoll G, Shah B, Naylor K, McArthur E, Luo B, Dixon SN, Hawley C, Ooi E, Viecelli AK, Wong G. Incidence of Major Adverse Cardiovascular Events and Cardiac Mortality in High-Risk Kidney-Only and Simultaneous Pancreas-Kidney Transplant Recipients. Kidney Int Rep. 2021 Feb 23;6(5):1423-1428. doi: 10.1016/j.ekir.2021.02.019. eCollection 2021 May. No abstract available.
PubMed 34013120Regolisti G, Maggiore U, Sabatino A, Gandolfini I, Pioli S, Torino C, Aucella F, Cupisti A, Pistolesi V, Capitanini A, Caloro G, Gregorini M, Battaglia Y, Mandreoli M, Dani L, Mosconi G, Bellizzi V, Di Iorio BR, Conti P, Fiaccadori E; Gruppo di Studio "Esercizio fisico nel paziente con insufficienza renale cronica" of the Societa Italiana di Nefrologia. Correction: Interaction of healthcare staff's attitude with barriers to physical activity in hemodialysis patients: A quantitative assessment. PLoS One. 2018 Jun 20;13(6):e0198987. doi: 10.1371/journal.pone.0198987. eCollection 2018.
PubMed 29924872Pang A, Lingham S, Zhao W, Leduc S, Rakel A, Sapir-Pichhadze R, Mathur S, Janaudis-Ferreira T. Physician Practice Patterns and Barriers to Counselling on Physical Activity in Solid Organ Transplant Recipients. Ann Transplant. 2018 May 22;23:345-359. doi: 10.12659/AOT.908629.
PubMed 29784902
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Dietary Counselling in Reducing the Cardiovascular Risk Score in Kidney Transplant Patients: KT- LIFESTYLE Study
- ClinicalTrials.gov ID
- NCT06806670
- Acronym / sponsor ID
- KT-LIFESTYLE / KT LIFESTYLE
- Conditions
- Kidney Transplant Recipients
- Keywords
- exercise, diet, cardiovascular risk, kidney transplant recipients, gut microbiota, lifestyle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- CNT (Centro Nazionale Trapianti), Azienda Unità Sanitaria Locale della Romagna
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 4 Feb 2025 (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 goal of this clinical trial is to assess whether, over an observation period of 3 years, there is a reduction in cardiovascular risk, and the extent of this reduction, in a group of adult kidney transplant patients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care'.
Detailed description
The main questions it aims to answer are:
- Prescribed exercise and dietary counselling could reduce of at least 1% in the cardiovascular risk score (by Framingham score) and cardiovascular biomarkers in kidney transplant recipients?
- How much can a lifestyle intervention affect kidney function, quality of life and the gut microbiota in this patient population?
Researchers will compare kidney transplant recipients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care' to see if there is a reduction in cardiovascular risk, BMI, inflammatory markers, improve of gut microbiota and perception of quality of life. In addition, a number of hospital admissions for important clinical events, the number of fatal and non-fatal cardiovascular events (MACE), and mortality from all causes will be assessed in the long term.
Participants will enroll from the Nephrology, Dialysis and Transplant Units and randomize in intervantion group (A) or control (B).
In group A/intervention, a tailored exercise programme combined with specific dietary counselling will be prescribed, in group B/control, generic advice on healthy lifestyles will be given (standard of care) without specific prescription.
In all patients, quality of life, gut microbiota, inflammatory and cardiovascular biomarkers (Framingham score, BNP, etc.), lipid profile and renal function over time will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, lifestyle intervention | Experimental | Behavioral: lifestyle interventionlifestyle intervention |
| Group B | No intervention | –standard of care |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically stabilised male and female kidney transplant patients (assessment by the referring transplant centre)
- Minimum age, 30 years;
- Maximum age, 69 years;
- Period since transplantation: from 6 months (subject to clinical stability being achieved) to 10 years;
- Organ function: eGFR (CKD-EPI formula) ≥ 30 mL/min/1.73m ;2
Key exclusion criteria (12 listed)
- Patients unable to follow the prescription,
- Recent acute cardiovascular event (< 2 months),
- Unstable angina,
- Hyperkinetic/hypokinetic arrhythmias not controlled by therapy, and with signs of haemodynamic impairment,
- Severe aortic stenosis,
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 |
|---|---|---|
| lifestyle interventionexercise and dietary counselling | Behavioural | Group A, lifestyle intervention |
Primary outcome
Cardiovascular risk reduction
Time frame: From enrollment to the end of the treatment (3 years)
reduction of at least 1% in the cardiovascular risk score - Framingham score - over the observation time. This score estimates the risk of developing a cardiovascular event over a 10-year period and is calculated in relation to the outcome from the following identifiable variables in normal clinical practice: * Sex * Age * Systolic pressure value * Treatment for hypertension (yes/no) * Smoker (yes/no) * Diabetes (yes/no) * HDL value * Total cholesterol value
7 secondary outcomes
Renal function
Time frame: From enrollment to the end of the treatment (3 years)
Gut microbiota analysis
Time frame: From enrollment to the end of the treatment (3 years)
Inflammatory status
Time frame: From enrollment to the end of the treatment (3 years)
Quality of Life (QoL)
Time frame: From enrollment to the end of the treatment (3 years)
Adherence to the lifestyle intervention
Time frame: From enrollment to the end of the treatment (3 years)
Cost-effectiveness of a healthy lifestyle intervention
Time frame: From enrollment to the end of the treatment (3 years)
Cardiovascular biomarkers
Time frame: From enrollment to the end of the treatment (3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Background: PubMed 23026587de Padua Netto MV, Bonfim TC, Costa EN, de Lima HV, Netto LC. Cardiovascular risk estimated in renal transplant recipients with the Framingham score. Transplant Proc. 2012 Oct;44(8):2337-40. doi: 10.1016/j.transproceed.2012.07.054.
- Background: PubMed 12234312Henry RM, Kostense PJ, Bos G, Dekker JM, Nijpels G, Heine RJ, Bouter LM, Stehouwer CD. Mild renal insufficiency is associated with increased cardiovascular mortality: The Hoorn Study. Kidney Int. 2002 Oct;62(4):1402-7. doi: 10.1111/j.1523-1755.2002.kid571.x.
- Background: PubMed 14604997Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Hypertension. 2003 Nov;42(5):1050-65. doi: 10.1161/01.HYP.0000102971.85504.7c. No abstract available.
- Background: PubMed 32316125Totti V, Fernhall B, Di Michele R, Todeschini P, La Manna G, Cappuccilli M, Angelini ML, De Fabritiis M, Merni F, Benedetti E, Roi GS, Nanni Costa A, Mosconi G. Longitudinal Analysis of Cardiovascular Risk Factors in Active and Sedentary Kidney Transplant Recipients. Medicina (Kaunas). 2020 Apr 16;56(4):183. doi: 10.3390/medicina56040183.
- Background: PubMed 33256487Masiero L, Puoti F, Bellis L, Lombardini L, Totti V, Angelini ML, Spazzoli A, Nanni Costa A, Cardillo M, Sella G, Mosconi G. Physical activity and renal function in the Italian kidney transplant population. Ren Fail. 2020 Nov 10;42(1):1192-1204. doi: 10.1080/0886022X.2020.1847723.
- Background: PubMed 31607623Totti V, Tame M, Burra P, Mosconi G, Roi GS, Sella G, Ermolao A, Ferrarese A, Sgarzi S, Savino G, Parodi G, Poggioli G, Ricchiuti A, Di Michele R, Trerotola M, Nanni Costa A. Physical Condition, Glycemia, Liver Function, and Quality of Life in Liver Transplant Recipients After a 12-Month Supervised Exercise Program. Transplant Proc. 2019 Nov;51(9):2952-2957. doi: 10.1016/j.transproceed.2019.03.087. Epub 2019 Oct 10.
- Background: PubMed 29507858Roi GS, Mosconi G, Totti V, Angelini ML, Brugin E, Sarto P, Merlo L, Sgarzi S, Stancari M, Todeschini P, La Manna G, Ermolao A, Tripi F, Andreoli L, Sella G, Anedda A, Stefani L, Galanti G, Di Michele R, Merni F, Trerotola M, Storani D, Nanni Costa A. Renal function and physical fitness after 12-mo supervised training in kidney transplant recipients. World J Transplant. 2018 Feb 24;8(1):13-22. doi: 10.5500/wjt.v8.i1.13.
- Background: PubMed 22818941Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8.
- Background: PubMed 33239047van der Ploeg HP, Bull FC. Invest in physical activity to protect and promote health: the 2020 WHO guidelines on physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):145. doi: 10.1186/s12966-020-01051-1.
- Background: PubMed 8193294Markell MS, Armenti V, Danovitch G, Sumrani N. Hyperlipidemia and glucose intolerance in the post-renal transplant patient. J Am Soc Nephrol. 1994 Feb;4(8 Suppl):S37-47. doi: 10.1681/ASN.V48s37.
- Background: PubMed 17037085Painter P. Exercise following organ transplantation: A critical part of the routine post transplant care. Ann Transplant. 2005;10(4):28-30.
- Background: PubMed 28270107Seoane-Pillado MT, Pita-Fernandez S, Valdes-Canedo F, Seijo-Bestilleiro R, Pertega-Diaz S, Fernandez-Rivera C, Alonso-Hernandez A, Gonzalez-Martin C, Balboa-Barreiro V. Incidence of cardiovascular events and associated risk factors in kidney transplant patients: a competing risks survival analysis. BMC Cardiovasc Disord. 2017 Mar 7;17(1):72. doi: 10.1186/s12872-017-0505-6.
- Individual participant dataSharing planned: No
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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.
Valentina Totti, PhD contact
Giuseppe Tarantino, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention in people with Kidney Transplant Recipients, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 4 Feb 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Tarantino, MD (0512144912, giuseppe.tarantino@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular risk reduction (time frame: From enrollment to the end of the treatment (3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06806670, which also lists 16 linked publications.
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 4 Feb 2025.