Kidney TransplantationPhase 4NCT04743453
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS.
A Phase 4 study testing Dapagliflozin in people with Kidney Transplantation and Diabetes Mellitus, Type 2, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Sodium-glucose co-transporter 2 (SGLT2) inhibitors reduce plasma glucose and haemoglobin A1c(HbA1c) in patients with type 2 diabetes mellitus by increasing urinary glucose excretion in a non-insulin-dependent fashion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Diabetes Mellitus, Type 2, Diabetes Complications
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Aug 2021to 2 Sep 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal Transplanted patients with one to 5 years after transplantation, being followed at the out-patient clinics of the HCFMUSP and HRim;
- ≥18years of age;
- 45 ≥ eGFR ≥ 25 mL/min/1.73m2 or 45<eGFR<60 ml/min/1.73m2 with a loss of eGFR of ≥10% in the last year.
Who cannot join
- Type 1 diabetes;
- New York Heart Association Class IV congestive heart failure;
- Myocardial infarction, unstable angina, stroke or transient ischaemic attack within 8 weeks prior to enrolment;
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 8weeks prior to enrolment;
- Any condition outside the renal and cardiovascular study area with a life expectancy of < 1 year based on investigator's clinical judgement;
- Hepatic impairment [aspartate transaminase or alanine transaminase >3 times the upper limit of normal (ULN) or total bilirubin >2 times the ULN at the time of enrolment;
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- Acute or chronic antibody mediated rejection;
- Albuminuria due to other causes (mTOR inhibitors, Polyoma nephropathy, lymphoproliferative disorder etc…)
- Patients with a previous medical history of recurrent urinary tract infections or severe genital infection;
- Renal biopsies showing acute or chronic anti-body mediated rejection, transplant glomerulopathy, BKV nephropathy.
- Patients under any other IS regimen besides Tacrolimus/MPA/Steroids
- Pregnant patients as well as those breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS: A Prospective, Randomized, Single-blinded, Placebo- Controlled Study.
Sodium-glucose co-transporter 2 (SGLT2) inhibitors reduce plasma glucose and haemoglobin A1c(HbA1c) in patients with type 2 diabetes mellitus by increasing urinary glucose excretion in a non-insulin-dependent fashion.
However, in some situations lead to a diminished number of functional glomeruli with a consequent hyperfiltration in the remaining ones. This fact may be where the use of SGLT2 inhibitor could attenuate the renal damage.
Read more
The purpose of our study is to evaluate the impact of using dapagliflozin on the renal functional deterioration of renal transplanted patients diabetics or not.
This is a prospective, randomized, single-blinded, double-center, controlled trial.
Patients will be randomized to add either Dapagliflozin 10 mg or Placebo to their treatment. Study drug will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose.
- Being tested
- Dapagliflozin, Placebo
- Keywords
- Kidney Transplantation, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin 10 mg: Study drug will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose.
PlaceboDrug
Placebo will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Not described Receives: Drug: Dapagliflozin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the mean ΔmGFR, between baseline and one year after randomization.
To evaluate the mean ΔmGFR, between baseline and one year after randomization between groups: Dapaglifozin and Placebo groups. (ΔmGFR is defind as the difference between measured GFR (mGFR) at baseline and at one year).
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 posted8 Feb 2021
- Study start17 Aug 2021
- Primary completion2 Sep 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to add either Dapagliflozin 10 mg or Placebo to their treatment. Study drug will be administered by once-daily orallly.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743453
- Sponsor's protocol ID
- 41012620.6.1001.0068
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2021
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
David-Neto E, David AER, Alves B, Reusing JO, Lembe C, Galante NZ, Silva R, de Souza PS, Nakamura M, Silva HT. The Effect of Adding Dapagliflozin on Chronic Renal Allograft Dysfunction: A Randomized, Prospective, Double-blind, Placebo-controlled Trial. Transplantation. 2026 Jul 1;110(7):e1527-e1538. doi: 10.1097/TP.0000000000005741. Epub 2026 May 8.
PubMed 42102257Gill M, Leung M, Luo CY, Cheung C, Beauchesne A, Chang D, Lan J, Johnston O. Erythrocytosis and thrombotic events in kidney transplant recipients prescribed a sodium glucose cotransport-2 inhibitor. Clin Transplant. 2023 Aug;37(8):e15013. doi: 10.1111/ctr.15013. Epub 2023 May 11.
PubMed 37170711
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS: A Prospective, Randomized, Single-blinded, Placebo- Controlled Study.
- ClinicalTrials.gov ID
- NCT04743453
- Acronym / sponsor ID
- 41012620.6.1001.0068
- Keywords
- Kidney Transplantation, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 8 Feb 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.
Sodium-glucose co-transporter 2 (SGLT2) inhibitors reduce plasma glucose and haemoglobin A1c(HbA1c) in patients with type 2 diabetes mellitus by increasing urinary glucose excretion in a non-insulin-dependent fashion.
However, in some situations lead to a diminished number of functional glomeruli with a consequent hyperfiltration in the remaining ones. This fact may be where the use of SGLT2 inhibitor could attenuate the renal damage.
The purpose of our study is to evaluate the impact of using dapagliflozin on the renal functional deterioration of renal transplanted patients diabetics or not.
This is a prospective, randomized, single-blinded, double-center, controlled trial.
Patients will be randomized to add either Dapagliflozin 10 mg or Placebo to their treatment. Study drug will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to add either Dapagliflozin 10 mg or Placebo to their treatment. Study drug will be administered by once-daily orallly.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Renal Transplanted patients with one to 5 years after transplantation, being followed at the out-patient clinics of the HCFMUSP and HRim;
- ≥18years of age;
- 45 ≥ eGFR ≥ 25 mL/min/1.73m2 or 45<eGFR<60 ml/min/1.73m2 with a loss of eGFR of ≥10% in the last year.
Key exclusion criteria (12 listed)
- Type 1 diabetes;
- New York Heart Association Class IV congestive heart failure;
- Myocardial infarction, unstable angina, stroke or transient ischaemic attack within 8 weeks prior to enrolment;
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 8weeks prior to enrolment;
- Any condition outside the renal and cardiovascular study area with a life expectancy of < 1 year based on investigator's clinical judgement;
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 |
|---|---|---|
| DapagliflozinDapagliflozin 10 mg: Study drug will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose. | Drug | Dapagliflozin |
| PlaceboPlacebo will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose. | Drug | Placebo |
Primary outcome
Evaluate the mean ΔmGFR, between baseline and one year after randomization.
Time frame: 12 months
To evaluate the mean ΔmGFR, between baseline and one year after randomization between groups: Dapaglifozin and Placebo groups. (ΔmGFR is defind as the difference between measured GFR (mGFR) at baseline and at one year).
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 5 Sep 2024.
- Derived from this study: PubMed 42102257David-Neto E, David AER, Alves B, Reusing JO, Lembe C, Galante NZ, Silva R, de Souza PS, Nakamura M, Silva HT. The Effect of Adding Dapagliflozin on Chronic Renal Allograft Dysfunction: A Randomized, Prospective, Double-blind, Placebo-controlled Trial. Transplantation. 2026 Jul 1;110(7):e1527-e1538. doi: 10.1097/TP.0000000000005741. Epub 2026 May 8.
- Derived from this study: PubMed 37170711Gill M, Leung M, Luo CY, Cheung C, Beauchesne A, Chang D, Lan J, Johnston O. Erythrocytosis and thrombotic events in kidney transplant recipients prescribed a sodium glucose cotransport-2 inhibitor. Clin Transplant. 2023 Aug;37(8):e15013. doi: 10.1111/ctr.15013. Epub 2023 May 11.
- 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. 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 Phase 4 study testing Dapagliflozin in people with Kidney Transplantation and Diabetes Mellitus, Type 2, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 5 Sep 2024. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the mean ΔmGFR, between baseline and one year after randomization. (time frame: 12 months). 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 NCT04743453, which also lists 2 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 5 Sep 2024.