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Could a common diabetes drug protect transplanted kidneys?

NCT ID NCT04965935

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether dapagliflozin, a drug used for type 2 diabetes, can lower blood pressure in people who have received a kidney transplant. Fifty-two participants took either the drug or a placebo for 12 weeks. The goal was to see if the drug helps control blood pressure and blood sugar, which are important for keeping the transplanted kidney healthy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dapagliflozin (a diabetes drug that helps lower blood sugar and blood pressure)
What this could lead to
If successful, this could point toward a new way to manage blood pressure and diabetes in kidney transplant recipients, potentially improving long-term outcomes.
What could go wrong
This is a small, early-phase trial with only 52 participants, so results may not apply to everyone. The drug also carries risks like dehydration or infections in this vulnerable population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

52 people

The number who actually took part.

Started

Jul 2021

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or females \>18 years old ≥ 6months after kidney transplantation; 2. In patients with T2D or PTDM, HbA1c \<12.0%; 3. eGFR ≥30 ml/min/1.73m\^2 (as per the CKD-EPI equation); 4. BMI ≤45kg/m\^2; 5. Blood pressure ≤160/90 and ≥90/60 at screening. Exclusion Criteria: 1. Diagnosis of type 1 diabetes; 2. Presence of severe peripheral vascular disease (i.e. prior amputation, gangrene, non-healing ulcer or ischemic rest pain); 3. Presence of acute coronary syndrome, stroke or transient ischemic attack in the 3 months prior to screening; 4. Prior episode of graft pyelonephritis in the 1 month prior to screening; 5. Episode of acute graft rejection in the 3 months prior to screening; 6. Initiation of a new immunosuppressive agent or discontinuation of an immunosuppressive agent in the 1 month prior to screening; 7. Untreated urinary or genital tract infection; 8. Severe hypoglycemia within 3 months of screening, or hypoglycemia unawareness; 9. Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control; 10. Participation in another trial with an investigational drug within 30 days of informed consent; 11. Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation; 12. Any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement. 13. Patients currently using antipsychotic medications. 14. Use of SGLT2 inhibitors within 1 month of starting the study.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplant recipients Post transplant diabetes mellitus Type 2 diabetes

Contacts and locations

Locations

  • Renal Physiology Laboratory

    Toronto, Ontario, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.