Kidney TransplantationNCT05013112
Ameliorating Metabolic Profiling After Kidney Transplantation (AMPKT)
A study testing SGLT2 inhibitor and Metformin in people with Kidney Transplantation and Metabolic Disorder, run by West China Hospital at 1 site in China.
Trial summary
Advances in patient selection, organ procurement and preservation, surgical technique, immunosuppression, and infection prevention have conferred significant decrease in rejection, infection, and subsequently improve cause-specific graft failure rates after kidney transplantation (KT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplantation, Metabolic Disorder, Metformin
- What is being tested?
- SGLT2 inhibitor and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- living-donor kidney transplantation;
- eGFR level > 45ml/min/1.73m2 at discharge;
- 18<Age<65 years;
- receiving standard triad immunosuppressive regimen.
Who cannot join
- previous therapy with metformin or SGLT 2 over the previous 3 months;
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 or more of upper limit of normal;
- Combined with HBV/HCV/HIV infection in the donor or recipient;
- Malignancy history in the donor and recipient; 6) organ transplant history in the recipient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ameliorating Metabolic Profiling After Kidney Transplantation (AMPKT): Protocol for an Open-label, Prospective, Randomized, 3-arm, Controlled Trial
Advances in patient selection, organ procurement and preservation, surgical technique, immunosuppression, and infection prevention have conferred significant decrease in rejection, infection, and subsequently improve cause-specific graft failure rates after kidney transplantation (KT). However, cardiovascular diseases (CVD) remained the main burden impairing both short-and long-term survival. Compared with the general population, conventional CVD risk factors, including obesity, liver and muscle insulin resistance, dyslipidemia, hypertension, and diabetes mellitus, are all highly prevalent in this population. Risk factors of these metabolic disorders are generally reported, including common risk factors and those specifically for kidney transplants, including long-term exposure to steroids and calcineurin inhibitors.
Previous studies demonstrated that adenosine 5'-monophosphate (AMP)-activated protein kinase (AMPK) is a central regulator of multiple metabolic pathways and a key player in regulating cellular energy metabolism. Activation of AMPK by pharmacological agents may hold a considerable potential to reverse the metabolic abnormalities in chronic metabolic diseases. Metformin, a widely used antidiabetic drug, have been reported to act as an AMPK activator by inhibiting complex I of the mitochondrial electron transport chain in many tissues, including adipose, skeletal muscle, and heart. A recent small clinical trial observed that metformin administration did improve some of the metabolic profiles for glucocorticoid-treated patients with inflammatory disease but without pre-existing diabetes. In addition, another antidiabetic drug sodium-glucose-cotransporter-2 (SGLT-2) inhibitors can improve metabolic parameters and cardiovascular risk in patients with or without diabetes in preclinical and clinical studies. A small clinical trial reported that compared to metformin, significant improvement in anthropometric parameters and body composition, in overweight and obese women with polycystic ovary syndrome after 12 weeks of treatment with empagliflozin. Hence, metformin and SGLT2 agents may be used as potential adjuvant therapies to improve metabolic disorders after KT.
However, both metformin and SGLT-2 inhibitors were not recommended in patients with impaired kidney function considering their elimination and action mechanism. Although several preliminary clinical trials showed that metformin and SGLT-2 inhibitors can be used safely and improve glucose control after KT, but they are small-sample sized and only include patients with diabetes. We will conduct a prospective clinical trial with the first aim of exploring the safety of metformin and SGLT-2 inhibitors in kidney transplant recipients with or without diabetes, and the second aim of exploring their roles in improving metabolic profiling.
- Conditions
- Kidney Transplantation, Metabolic Disorder, Metformin, Empagliflozin
- Being tested
- SGLT2 inhibitor, Metformin, Placebo
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Empagliflozin 10mg once daily from discharge
MetforminDrug
Metformin 500mg twice daily from discharge
PlaceboOther
Placebo group
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Patients receive no additional therapy. Receives: Other: Placebo |
| Metformin group | Experimental | Patients receive metformin 500mg twice daily from discharge. Receives: Drug: Metformin |
| Empagliflozin | Experimental | Patients receive Empagliflozin once daily from discharge. Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the differences in the visceral-to-subcutaneous fat area ratio over 12 months among three groups.
Based on previous study, visceral-to-subcutaneous fat area ratio, evaluated by CT, was generally reported as a surrogate for metabolic risk and was markedly raised in patients with long-term exposure to steroids. Hence, the primary outcome was the differences in the visceral-to-subcutaneous fat area ratio over 12 months among three groups.
Measured: 12 months
Secondary outcomes (3)
glycometabolic disorder
glycometabolic disorder was evaluated by fasting plasma glucose levels.
Measured: 12 months
lipid metabolism
lipid metabolism was evaluated by serum triglyceride levels.
Measured: 12 months
inflammatory status
inflammatory status was evaluated by C-reactive protein levels.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Jan 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Lin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013112
- Sponsor's protocol ID
- WestChinaH-Metformin
- Status last verified
- Mar 2026
- First submitted
- 20 Jul 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ameliorating Metabolic Profiling After Kidney Transplantation (AMPKT): Protocol for an Open-label, Prospective, Randomized, 3-arm, Controlled Trial
- ClinicalTrials.gov ID
- NCT05013112
- Acronym / sponsor ID
- WestChinaH-Metformin
- Conditions
- Kidney Transplantation, Metabolic Disorder, Metformin, Empagliflozin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Aug 2021 (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.
Advances in patient selection, organ procurement and preservation, surgical technique, immunosuppression, and infection prevention have conferred significant decrease in rejection, infection, and subsequently improve cause-specific graft failure rates after kidney transplantation (KT). However, cardiovascular diseases (CVD) remained the main burden impairing both short-and long-term survival. Compared with the general population, conventional CVD risk factors, including obesity, liver and muscle insulin resistance, dyslipidemia, hypertension, and diabetes mellitus, are all highly prevalent in this population. Risk factors of these metabolic disorders are generally reported, including common risk factors and those specifically for kidney transplants, including long-term exposure to steroids and calcineurin inhibitors.
Previous studies demonstrated that adenosine 5'-monophosphate (AMP)-activated protein kinase (AMPK) is a central regulator of multiple metabolic pathways and a key player in regulating cellular energy metabolism. Activation of AMPK by pharmacological agents may hold a considerable potential to reverse the metabolic abnormalities in chronic metabolic diseases. Metformin, a widely used antidiabetic drug, have been reported to act as an AMPK activator by inhibiting complex I of the mitochondrial electron transport chain in many tissues, including adipose, skeletal muscle, and heart. A recent small clinical trial observed that metformin administration did improve some of the metabolic profiles for glucocorticoid-treated patients with inflammatory disease but without pre-existing diabetes. In addition, another antidiabetic drug sodium-glucose-cotransporter-2 (SGLT-2) inhibitors can improve metabolic parameters and cardiovascular risk in patients with or without diabetes in preclinical and clinical studies. A small clinical trial reported that compared to metformin, significant improvement in anthropometric parameters and body composition, in overweight and obese women with polycystic ovary syndrome after 12 weeks of treatment with empagliflozin. Hence, metformin and SGLT2 agents may be used as potential adjuvant therapies to improve metabolic disorders after KT.
However, both metformin and SGLT-2 inhibitors were not recommended in patients with impaired kidney function considering their elimination and action mechanism. Although several preliminary clinical trials showed that metformin and SGLT-2 inhibitors can be used safely and improve glucose control after KT, but they are small-sample sized and only include patients with diabetes. We will conduct a prospective clinical trial with the first aim of exploring the safety of metformin and SGLT-2 inhibitors in kidney transplant recipients with or without diabetes, and the second aim of exploring their roles in improving metabolic profiling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: PlaceboPatients receive no additional therapy. |
| Metformin group | Experimental | Drug: MetforminPatients receive metformin 500mg twice daily from discharge. |
| Empagliflozin | Experimental | Drug: SGLT2 inhibitorPatients receive Empagliflozin once daily from discharge. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- living-donor kidney transplantation;
- eGFR level > 45ml/min/1.73m2 at discharge;
- 18<Age<65 years;
- receiving standard triad immunosuppressive regimen.
Key exclusion criteria (4 listed)
- previous therapy with metformin or SGLT 2 over the previous 3 months;
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 or more of upper limit of normal;
- Combined with HBV/HCV/HIV infection in the donor or recipient;
- Malignancy history in the donor and recipient; 6) organ transplant history in the recipient.
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 |
|---|---|---|
| SGLT2 inhibitorEmpagliflozin 10mg once daily from discharge | Drug | Empagliflozin |
| MetforminMetformin 500mg twice daily from discharge | Drug | Metformin group |
| PlaceboPlacebo group | Other | Placebo group |
Primary outcome
The primary outcome was the differences in the visceral-to-subcutaneous fat area ratio over 12 months among three groups.
Time frame: 12 months
Based on previous study, visceral-to-subcutaneous fat area ratio, evaluated by CT, was generally reported as a surrogate for metabolic risk and was markedly raised in patients with long-term exposure to steroids. Hence, the primary outcome was the differences in the visceral-to-subcutaneous fat area ratio over 12 months among three groups.
3 secondary outcomes
glycometabolic disorder
Time frame: 12 months
lipid metabolism
Time frame: 12 months
inflammatory status
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGLT2 inhibitor and Metformin in people with Kidney Transplantation and Metabolic Disorder, run by West China Hospital at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 18 Mar 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was the differences in the visceral-to-subcutaneous fat area ratio over 12 months among three groups. (time frame: 12 months). 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 18 Mar 2026.