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SGLT2 Inhibitor

Empagliflozin for Kidney Transplant Complications (CREST-KT Trial)

Phase 2
Recruiting
Led By Myles Wolf, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estimated glomerular filtration rate (eGFR) equal to or greater than 30ml/min/1.73m squared at screening
Standard immunosuppression, including calcineurin inhibitor, Mycophenolate Mofetil or Sodium and a glucocorticoid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, months 3,6,9,12,15 and 18
Awards & highlights

CREST-KT Trial Summary

This trial is testing a diabetes medication in people who have had a kidney transplant. Half the patients have diabetes and half don't. The patients will be given either the medication or a placebo and monitored to see if the medication improves outcomes.

Who is the study for?
This trial is for kidney transplant recipients, with or without type 2 diabetes, who are 12-60 months post-transplant. They must be on standard immunosuppression and have a stable kidney function (eGFR ≥30). Excluded are those with recent severe rejection episodes, pregnant/nursing women, uncircumcised men, active heavy anticoagulant users, Type I diabetics, multiple organ transplants or high hemoglobin A1c levels.Check my eligibility
What is being tested?
The CREST-KT study tests the effects of Empagliflozin (a diabetes medication) in kidney transplant patients. It's a double-blind trial where participants are randomly assigned to receive either Empagliflozin or a placebo. The ratio of drug to placebo is 2:1 among both diabetic and non-diabetic groups.See study design
What are the potential side effects?
Potential side effects of Empagliflozin include urinary tract infections due to increased sugar in urine which bacteria feed on; dehydration because it causes the body to expel more water; low blood pressure; and ketoacidosis – a serious condition related to insulin levels.

CREST-KT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by eGFR, is at least 30ml/min/1.73m^2.
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I am on standard drugs to suppress my immune system.

CREST-KT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, months 3,6,9,12,15 and 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months 3,6,9,12,15 and 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in blood insulin level
Change in cardiac structure
Change in fasting blood sugar
+4 more
Secondary outcome measures
Change in kidney biopsy as measured by percentage of interstitial fibrosis
Changes in Hemoglobin A1C as measured by blood work
Other outcome measures
Adverse events will be collected form the medical record and patient report

CREST-KT Trial Design

2Treatment groups
Active Control
Group I: Arm I: With Type II DiabetesActive Control2 Interventions
Kidney Transplant recipient with Type II diabetes, randomized to either Empagliflozin or a placebo.
Group II: Arm 2: Without DiabetesActive Control2 Interventions
Kidney Transplant recipient without Type II diabetes, randomized to either Empagliflozin or a placebo

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,375 Previous Clinical Trials
3,426,851 Total Patients Enrolled
Myles Wolf, MDPrincipal InvestigatorDuke University

Media Library

Empagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04906213 — Phase 2
Type 2 Diabetes Research Study Groups: Arm I: With Type II Diabetes, Arm 2: Without Diabetes
Type 2 Diabetes Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT04906213 — Phase 2
Empagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906213 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is Arm 2: Without Diabetes most typically employed?

"Arm 2: Without Diabetes is an oft-used pharmaceutical to treat diabetes. Additionally, it has been known to be effective in managing other issues such as inadequate response to monotherapy and lifestyle modifications like diet and exercise."

Answered by AI

Are there any vacancies for this research study at the moment?

"Per the clinicaltrials.gov website, this medical study is actively in search of participants. The date of its initial posting was July 25th 2022 and most recently updated on September 26th 2022."

Answered by AI

Has a similar experiment been conducted previously?

"Currently, there are 63 ongoing trials concerning Arm 2: Without Diabetes in 50 countries across 235 cities. This research began back in 2014 when AstraZeneca sponsored a trial encompassing 700 participants to reach the N/A drug approval stage. Since then, 18452 studies have been conducted on this topic."

Answered by AI

How many participants are engaged in this research?

"Affirmative, the information hosted on clinicaltrials.gov signals that this medical experiment is actively enlisting volunteers. Initially posted on July 25th 2022 and last updated September 26th of the same year, it seeks 72 individuals from a single site for study participation."

Answered by AI

What are the implications of Arm 2: Without Diabetes for human health?

"Taking into account the safety data gathered from Phase 2 clinical trials, our team at Power assigned a score of 2 to Arm 2: Without Diabetes. This is due to the lack of efficacy information as compared with existing safety studies."

Answered by AI
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~39 spots leftby Jul 2026