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Can a diabetes drug shield transplanted kidneys?

NCT ID NCT06560801

Disease control Sponsor: University of Erlangen-Nürnberg Medical School Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether dapagliflozin, a drug used for diabetes and kidney protection, can improve kidney structure and blood flow in people who received a kidney transplant one year ago. About 48 participants will be randomly assigned to take dapagliflozin or standard care alone. Researchers will examine kidney biopsies and MRI scans to look for changes in inflammation, scarring, and perfusion.

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 protect the kidneys)
What this could lead to
If it works, this could show that dapagliflozin helps preserve kidney health in transplant patients, potentially leading to better long-term outcomes.
What could go wrong
This is a small, early-phase study (48 people) looking at tissue changes, not hard outcomes like kidney failure. The drug may not show clear benefits or could cause side effects.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

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

18 to 75 years

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: * Female and male patients aged between 18 and 75 years * Patients with renal transplant having a stable eGFR, who are in stable condition, 9 months after transplantation, irrespective of their diabetes status * Females of child bearing potential must be using adequate contraceptive precautions * Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit * Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form Exclusion Criteria: * Type 1 diabetes mellitus. * HbA1c \> 10% * Use of SGLT-2 inhibitor within the past 2 months * Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion. * eGFR \<25 ml/min/1.73m² (CKD-EPI Formula). * Uncontrolled arterial hypertension (RR \> 180/110 mmHg). * Congestive heart failure (CHF) NYHA stage IV. * Recurrent urinary tract infections (bacterial or fungal) * Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of the drug. * Significant laboratory abnormalities such as SGOT or SGPT levels more than 5 x above the upper limit of normal range. * Antihypertensives are allowed but should be kept stable throughout the study period. * Statins and other antihyperlipidemic drugs are allowed but should be kept stable throughout the study period. * Drug or alcohol abusus * Pregnant or breast-feeding patients * Patients with contraindications to MRI

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

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

Chronic kidney diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Research Center (CRC)

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

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