Kidney Transplant RecipientsVBRTKIDNEYNCT07370727
Velocity-Based Resistance Training in Kidney Transplant Recipients
A study testing Velocity-Based Resistance Training - Submaximal Velocity Protocol and Velocity-Based Resistance Training - Maximal Velocity Protocol in people with Kidney Transplant Recipients and Metabolic Syndrome, run by Fundación Universitaria del Area Andina at 1 site in Colombia.
Trial summary
This randomized controlled trial aims to evaluate the effects of velocity-based resistance training on renal function and metabolic health in kidney transplant recipients. Participants will be randomized into two groups performing resistance training at different execution velocities (maximal intended vs. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Kidney Transplant Recipients, Metabolic Syndrome, Cardiovascular Risk Factors
- What is being tested?
- Velocity-Based Resistance Training - Submaximal Velocity Protocol and Velocity-Based Resistance Training - Maximal Velocity Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteColombia
- Study dates
- 29 Oct 2025to 31 Dec 2027
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged 18 to 50 years.
- Kidney transplant performed ≥12 months before enrollment.
- Stable graft function in the previous 6 months (serum creatinine < 1.5 mg/dL, no rejection episodes).
- Written medical clearance from a nephrologist to perform moderate-to-vigorous physical activity.
- Signed informed consent.
Who cannot join
- Active autoimmune disorders.
- Recent coronary disease (≤6 months).
- Severe musculoskeletal limitations incompatible with resistance training.
- Diagnosis of diabetes mellitus (pre- or post-transplant).
- Current active infection.
- Use of immunosuppressive drugs with contraindications for exercise (e.g., mTOR inhibitors at baseline).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Colombia
Bogotá, Bogota D.C., 0000
Jhonatan C peña, Master in Physical Activity, 3125924821 ext. 57, jpena69@areandina.edu.co
About this study
Official title: Effects of Velocity-Based Resistance Training on Renal Function and Metabolic Health in Kidney Transplant Recipients: Protocol for a Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of velocity-based resistance training on renal function and metabolic health in kidney transplant recipients. Participants will be randomized into two groups performing resistance training at different execution velocities (maximal intended vs. submaximal controlled). The intervention will last 12 weeks and include multi-joint exercises (squat, bench press, military press). Primary outcomes include renal function (serum creatinine, eGFR, blood urea nitrogen, uric acid) and metabolic markers (HDL, triglycerides, glucose, waist circumference, blood pressure). Secondary outcomes include muscle strength, force-velocity profile, anthropometry, physical activity, fitness perception, and adherence to immunosuppressive medication.
Read the detailed description
This randomized controlled trial will examine the physiological and metabolic responses to different resistance training velocities in kidney transplant recipients. Participants will be randomized to perform either maximal-velocity or submaximal-velocity resistance exercises for 12 weeks. Each session will include multi-joint movements (bench press, squat, overhead press) using a Smith machine. Training loads will be individualized (20-60% 1RM) and monitored using a linear encoder to control velocity loss. Primary endpoints are renal function and metabolic health markers, while secondary outcomes include neuromuscular performance and adherence to immunosuppressive therapy. The study has received ethics approval from Fundación Universitaria del Área Andina (Acta 15, April 22, 2025).
- Being tested
- Velocity-Based Resistance Training - Submaximal Velocity Protocol, Velocity-Based Resistance Training - Maximal Velocity Protocol
- Keywords
- Kidney Transplant, Renal Transplant, Velocity based resistance training, Metabolic Health, Exercise Intervention, Glomerular Filtration Rate (eGFR)
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velocity-Based Resistance Training - Submaximal Velocity ProtocolOther
A 12-week supervised resistance training program performed 3 sessions per week. Exercises will include bench press, squat, and shoulder press in Smith machine. Participants will execute each repetition at ~50% of maximal concentric velocity, with sets completed according to predetermined repetitions (20-30 depending on load, 20-60% 1RM).
Velocity-Based Resistance Training - Maximal Velocity ProtocolOther
A 12-week supervised resistance training program performed 3 sessions per week. Exercises will include bench press, squat, and shoulder press in Smith machine. Participants will execute each repetition at maximal concentric velocity, with sets terminated at 20% velocity loss. Training loads will increase progressively (20-60% 1RM).
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Maximal Velocity Group | Experimental | Participants will perform velocity-based resistance training at maximal intended concentric velocity. Training load will progress from 20% to 60% of 1RM. Each set will be terminated once a 20% loss of movement velocity is reached. Receives: Other: Velocity-Based Resistance Training - Maximal Velocity Protocol |
| Submaximal Velocity Group | Active comparator | Participants will perform supervised velocity-based resistance training for 12 weeks, 3 sessions per week. Each repetition will be executed at approximately 50% of maximal concentric velocity. Training load will progress from 20% to 60% of 1RM, with sets completed according to a predetermined number of repetitions (20-30 depending on load). Receives: Other: Velocity-Based Resistance Training - Submaximal Velocity Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine (mg/dL) - change from baseline
Serum creatinine will be measured from venous blood samples processed in an external certified laboratory (IDIME, Bogotá). This parameter will serve as a biomarker of renal graft function.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) - change from baseline
The estimated glomerular filtration rate (eGFR) will be calculated from serum creatinine using validated equations (CKD-EPI or MDRD). This measure will serve as the most sensitive indicator of renal graft function.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Blood urea nitrogen (BUN, mg/dL) - change from baseline
Blood urea nitrogen will be measured to monitor renal clearance capacity and metabolic status.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Serum Uric Acid (mg/dL)
Serum uric acid will be measured as a biomarker of renal excretory capacity and cardiovascular risk.
Measured: Baseline and week 13 (after completion of 12-week intervention)
HDL cholesterol (mg/dL) - change from baseline
HDL cholesterol will be measured as a protective lipid biomarker inversely associated with metabolic and cardiovascular risk.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Triglycerides (mg/dL) - change from baseline
Serum triglycerides will be measured to evaluate metabolic health and risk of cardiovascular disease.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Fasting glucose (mg/dL) - change from baseline
Fasting blood glucose will be measured through enzymatic methods to evaluate glycemic control.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Waist circumference (cm) - change from baseline
Waist circumference will be measured at the narrowest point of the torso, midway between the lower margin of the ribs and the iliac crest, following ISAK recommendations. This anthropometric variable will serve as a key component of metabolic syndrome diagnosis.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Metabolic Risk Index (z-score composite)
A composite metabolic risk index will be calculated from triglycerides, LDL, HDL, glucose, and systolic/diastolic blood pressure values. Each variable will be standardized as z-scores; HDL will be multiplied by -1 due to its inverse relationship with cardiovascular risk. The final score will be the sum of standardized values.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Secondary outcomes (6)
Handgrip strength
Handgrip strength will be assessed using a digital dynamometer (Takei Scientific Instruments, Tokyo). Two trials per hand, best value recorded. This test reflects overall muscle strength.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Body Composition (fat percent, muscle percent, visceral fat)
Body composition will be assessed using segmental bioelectrical impedance analysis (Tanita IRONMAN BC-1500). Measurements will include fat percentage, muscle percentage, and visceral fat.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Force-Velocity Profile
:The force-velocity profile will be assessed using a linear encoder (T-Force) during three multi-joint exercises (bench press, squat, overhead press). The relationship between force and velocity will be calculated to estimate neuromuscular performance.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Body Height (cm)
Body height will be measured with a digital stadiometer following the Frankfurt plane reference to ensure standardized posture.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Relative Handgrip Strength (kg/kg body weight)
Relative handgrip strength will be calculated by dividing the maximum handgrip force by body weight to account for body size.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Comorbidity and Immunosuppressive Therapy Questionnaire
A structured questionnaire will be used to record comorbidities and medication adherence. Adherence will be rated on a 5-point Likert scale (1 = never adherent, 5 = always adherent), where higher scores indicate better adherence.
Measured: Baseline and week 13 (after completion of 12-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start29 Oct 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria del Area Andina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jhonatan Camilo Peña Ibagon, Fundación Universitaria del Area Andina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370727
- Sponsor's protocol ID
- CV2025-IMED-B-13434
- Acronym
- VBRTKIDNEY
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Michou V, Nikodimopoulou M, Liakopoulos V, Anifanti M, Papagianni A, Zembekakis P, Deligiannis A, Kouidi E. Home-Based Exercise Training and Cardiac Autonomic Neuropathy in Kidney Transplant Recipients with Type-II Diabetes Mellitus. Life (Basel). 2023 Jun 14;13(6):1394. doi: 10.3390/life13061394.
PubMed 37374177Pena JC, Sanchez-Guette L, Lombo C, Pinto E, Collazos C, Tovar B, Bonilla DA, Cardozo LA, Tellez LA. Characterization of Load Components in Resistance Training Programs for Kidney Transplant Recipients: A Scoping Review. Sports (Basel). 2025 May 19;13(5):153. doi: 10.3390/sports13050153.
PubMed 40423289Lima PS, de Campos AS, de Faria Neto O, Ferreira TCA, Amorim CEN, Stone WJ, Prestes J, Garcia AMC, Urtado CB. Effects of Combined Resistance Plus Aerobic Training on Body Composition, Muscle Strength, Aerobic Capacity, and Renal Function in Kidney Transplantation Subjects. J Strength Cond Res. 2021 Nov 1;35(11):3243-3250. doi: 10.1519/JSC.0000000000003274.
PubMed 31714457Hernandez Sanchez S, Carrero JJ, Morales JS, Ruiz JR. Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. Scand J Med Sci Sports. 2021 Feb;31(2):473-479. doi: 10.1111/sms.13853. Epub 2020 Oct 23.
PubMed 33038051Pena Ibagon JC, Vasquez Osorio F, Collazos Morales CA, Tovar BE, Martin WF, Pardo YR, Tellez LA. Effects of Velocity-Based Resistance Training on Renal Function and Metabolic Health in Kidney Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 10;15:e94010. doi: 10.2196/94010.
PubMed 42430723
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Velocity-Based Resistance Training on Renal Function and Metabolic Health in Kidney Transplant Recipients: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07370727
- Acronym / sponsor ID
- VBRTKIDNEY / CV2025-IMED-B-13434
- Keywords
- Kidney Transplant, Renal Transplant, Velocity based resistance training, Metabolic Health, Exercise Intervention, Glomerular Filtration Rate (eGFR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fundación Universitaria del Area AndinaUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2026 (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.
This randomized controlled trial aims to evaluate the effects of velocity-based resistance training on renal function and metabolic health in kidney transplant recipients. Participants will be randomized into two groups performing resistance training at different execution velocities (maximal intended vs. submaximal controlled). The intervention will last 12 weeks and include multi-joint exercises (squat, bench press, military press). Primary outcomes include renal function (serum creatinine, eGFR, blood urea nitrogen, uric acid) and metabolic markers (HDL, triglycerides, glucose, waist circumference, blood pressure). Secondary outcomes include muscle strength, force-velocity profile, anthropometry, physical activity, fitness perception, and adherence to immunosuppressive medication.
Detailed description
This randomized controlled trial will examine the physiological and metabolic responses to different resistance training velocities in kidney transplant recipients. Participants will be randomized to perform either maximal-velocity or submaximal-velocity resistance exercises for 12 weeks. Each session will include multi-joint movements (bench press, squat, overhead press) using a Smith machine. Training loads will be individualized (20-60% 1RM) and monitored using a linear encoder to control velocity loss. Primary endpoints are renal function and metabolic health markers, while secondary outcomes include neuromuscular performance and adherence to immunosuppressive therapy. The study has received ethics approval from Fundación Universitaria del Área Andina (Acta 15, April 22, 2025).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - Maximal Velocity Group | Experimental | Other: Velocity-Based Resistance Training - Maximal Velocity ProtocolParticipants will perform velocity-based resistance training at maximal intended concentric velocity. Training load will progress from 20% to 60% of 1RM. Each set will be terminated once a 20% loss of movement velocity is reached. |
| Submaximal Velocity Group | Active comparator | Other: Velocity-Based Resistance Training - Submaximal Velocity ProtocolParticipants will perform supervised velocity-based resistance training for 12 weeks, 3 sessions per week. Each repetition will be executed at approximately 50% of maximal concentric velocity. Training load will progress from 20% to 60% of 1RM, with sets completed according to a predetermined number of repetitions (20-30 depending on load). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged 18 to 50 years.
- Kidney transplant performed ≥12 months before enrollment.
- Stable graft function in the previous 6 months (serum creatinine < 1.5 mg/dL, no rejection episodes).
- Written medical clearance from a nephrologist to perform moderate-to-vigorous physical activity.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Active autoimmune disorders.
- Recent coronary disease (≤6 months).
- Severe musculoskeletal limitations incompatible with resistance training.
- Diagnosis of diabetes mellitus (pre- or post-transplant).
- Current active infection.
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 |
|---|---|---|
| Velocity-Based Resistance Training - Submaximal Velocity ProtocolA 12-week supervised resistance training program performed 3 sessions per week. Exercises will include bench press, squat, and shoulder press in Smith machine. Participants will execute each repetition at ~50% of maximal concentric velocity, with sets completed according to predetermined repetitions (20-30 depending on load, 20-60% 1RM). | Other | Submaximal Velocity Group |
| Velocity-Based Resistance Training - Maximal Velocity ProtocolA 12-week supervised resistance training program performed 3 sessions per week. Exercises will include bench press, squat, and shoulder press in Smith machine. Participants will execute each repetition at maximal concentric velocity, with sets terminated at 20% velocity loss. Training loads will increase progressively (20-60% 1RM). | Other | Experimental - Maximal Velocity Group |
Primary outcome
Serum creatinine (mg/dL) - change from baseline
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Serum creatinine will be measured from venous blood samples processed in an external certified laboratory (IDIME, Bogotá). This parameter will serve as a biomarker of renal graft function.
Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) - change from baseline
Time frame: Baseline and week 13 (after completion of 12-week intervention)
The estimated glomerular filtration rate (eGFR) will be calculated from serum creatinine using validated equations (CKD-EPI or MDRD). This measure will serve as the most sensitive indicator of renal graft function.
Blood urea nitrogen (BUN, mg/dL) - change from baseline
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Blood urea nitrogen will be measured to monitor renal clearance capacity and metabolic status.
Serum Uric Acid (mg/dL)
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Serum uric acid will be measured as a biomarker of renal excretory capacity and cardiovascular risk.
HDL cholesterol (mg/dL) - change from baseline
Time frame: Baseline and week 13 (after completion of 12-week intervention)
HDL cholesterol will be measured as a protective lipid biomarker inversely associated with metabolic and cardiovascular risk.
Triglycerides (mg/dL) - change from baseline
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Serum triglycerides will be measured to evaluate metabolic health and risk of cardiovascular disease.
Fasting glucose (mg/dL) - change from baseline
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Fasting blood glucose will be measured through enzymatic methods to evaluate glycemic control.
Waist circumference (cm) - change from baseline
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Waist circumference will be measured at the narrowest point of the torso, midway between the lower margin of the ribs and the iliac crest, following ISAK recommendations. This anthropometric variable will serve as a key component of metabolic syndrome diagnosis.
Metabolic Risk Index (z-score composite)
Time frame: Baseline and week 13 (after completion of 12-week intervention)
A composite metabolic risk index will be calculated from triglycerides, LDL, HDL, glucose, and systolic/diastolic blood pressure values. Each variable will be standardized as z-scores; HDL will be multiplied by -1 due to its inverse relationship with cardiovascular risk. The final score will be the sum of standardized values.
6 secondary outcomes
Handgrip strength
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Body Composition (fat percent, muscle percent, visceral fat)
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Force-Velocity Profile
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Body Height (cm)
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Relative Handgrip Strength (kg/kg body weight)
Time frame: Baseline and week 13 (after completion of 12-week intervention)
Comorbidity and Immunosuppressive Therapy Questionnaire
Time frame: Baseline and week 13 (after completion of 12-week intervention)
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 27 Jan 2026.
- Background: PubMed 37374177Michou V, Nikodimopoulou M, Liakopoulos V, Anifanti M, Papagianni A, Zembekakis P, Deligiannis A, Kouidi E. Home-Based Exercise Training and Cardiac Autonomic Neuropathy in Kidney Transplant Recipients with Type-II Diabetes Mellitus. Life (Basel). 2023 Jun 14;13(6):1394. doi: 10.3390/life13061394.
- Background: PubMed 40423289Pena JC, Sanchez-Guette L, Lombo C, Pinto E, Collazos C, Tovar B, Bonilla DA, Cardozo LA, Tellez LA. Characterization of Load Components in Resistance Training Programs for Kidney Transplant Recipients: A Scoping Review. Sports (Basel). 2025 May 19;13(5):153. doi: 10.3390/sports13050153.
- Background: PubMed 31714457Lima PS, de Campos AS, de Faria Neto O, Ferreira TCA, Amorim CEN, Stone WJ, Prestes J, Garcia AMC, Urtado CB. Effects of Combined Resistance Plus Aerobic Training on Body Composition, Muscle Strength, Aerobic Capacity, and Renal Function in Kidney Transplantation Subjects. J Strength Cond Res. 2021 Nov 1;35(11):3243-3250. doi: 10.1519/JSC.0000000000003274.
- Background: PubMed 33038051Hernandez Sanchez S, Carrero JJ, Morales JS, Ruiz JR. Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. Scand J Med Sci Sports. 2021 Feb;31(2):473-479. doi: 10.1111/sms.13853. Epub 2020 Oct 23.
- Derived from this study: PubMed 42430723Pena Ibagon JC, Vasquez Osorio F, Collazos Morales CA, Tovar BE, Martin WF, Pardo YR, Tellez LA. Effects of Velocity-Based Resistance Training on Renal Function and Metabolic Health in Kidney Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 10;15:e94010. doi: 10.2196/94010.
- Fundación Universitaria del Área AndinaLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Velocity-Based Resistance Training - Submaximal Velocity Protocol and Velocity-Based Resistance Training - Maximal Velocity Protocol in people with Kidney Transplant Recipients and Metabolic Syndrome, run by Fundación Universitaria del Area Andina at 1 site in Colombia.
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 5 inclusion and 6 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 27 Jan 2026. 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 Colombia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine (mg/dL) - change from baseline (time frame: Baseline and week 13 (after completion of 12-week intervention)). The study lists 9 primary outcomes in all. 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 NCT07370727, which also lists 5 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 27 Jan 2026.