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Sodium Glucose Co-Transporter-2 Inhibitor
SGLT2 Inhibitor + GLP-1 Agonist for Kidney Transplant Recipients (HALLMARK Trial)
Phase 2
Recruiting
Led By Sunita Singh, MD MSc FRCPC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ]
Awards & highlights
HALLMARK Trial Summary
This trial looks at the effects of a combination of two drugs on 20 kidney transplant recipients, with and without type 2 diabetes.
Who is the study for?
This trial is for kidney transplant recipients aged 18 or older, with a BMI of 18.5-40 and stable blood pressure. They must be at least 3 months post-transplantation with decent kidney function (eGFR ≥20). Diabetics can join if their HbA1c is below 12%. Exclusions include recent use of similar drugs, risk of dehydration or electrolyte issues, severe infections, uncontrolled hypertension, hypersensitivity to the drugs tested, pregnancy, certain cancers or genetic conditions.Check my eligibility
What is being tested?
The study tests the combination therapy using Dapagliflozin and Semaglutide over a period of 12 weeks in kidney transplant recipients (KTR), both with and without type 2 diabetes (T2D). It aims to assess how effective this treatment is short-term and what safety concerns might arise.See study design
What are the potential side effects?
Potential side effects may include risks related to volume depletion like low blood pressure or imbalance in body salts; genital or urinary tract infections; possible allergic reactions; hypoglycemia especially in diabetic patients; pancreatitis; and possibly others not listed.
HALLMARK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proximal tubular natriuresis with combination therapy
Proximal tubular natriuresis with monotherapy
Secondary outcome measures
Arterial stiffness
Change in body composition (percent body mass, body fat, and muscle mass)
Change in body weight
+16 moreHALLMARK Trial Design
2Treatment groups
Experimental Treatment
Group I: SemaglutideExperimental Treatment2 Interventions
Semaglutide Subcutaneous 0.25mg once weekly for 4 weeks, then 0.5mg once weekly for 4 weeks, then 1mg once weekly for 4 weeks.
Group II: DapagliflozinExperimental Treatment2 Interventions
Dapagliflozin Tablets Total Dose 10mg daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin 10 MG
2019
Completed Phase 4
~310
Semaglutide, 1.0 mg/mL
2018
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,160 Total Patients Enrolled
Sunita Singh, MD MSc FRCPCPrincipal InvestigatorUniversity Health Network, Toronto General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for BK, CMV, or EBV infection.I am over 18 and had a kidney transplant more than 3 months ago.I have had an amputation or experience pain at rest due to poor blood flow.I have not had a heart attack, mini-stroke, or stroke in the last 30 days.I have had unstable diabetic eye problems in the last year.My kidney function is rapidly getting worse, or I need a kidney biopsy soon.I or my family have a history of medullary thyroid cancer or MEN2B.I often experience low blood sugar episodes.I have been hospitalized or needed treatment for diabetic ketoacidosis recently.I have had pancreatitis before.I am at risk of dehydration, low blood pressure, or electrolyte issues.I understand and can follow the study's requirements.I have not taken SGLT2 inhibitors or GLP-1 receptor agonists in the last 30 days.My HbA1c level is below 12.0%.I have had repeated kidney infections or need a catheter.I am not pregnant, nursing, or planning to become pregnant during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Semaglutide
- Group 2: Dapagliflozin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration (FDA) given its stamp of approval to Semaglutide?
"Despite being a Phase 2 trial, Semaglutide scored a safety rating of two due to the presence of some evidence suggesting its general security. No data was found supporting efficacy."
Answered by AI
Is recruitment still underway for this experiment?
"As per the clinicaltrials.gov website, this specific trial is not presently enrolling subjects. The initial post was made on September 1st 2023 and edited as recently as July 6th 2023. However, there are 15 other studies that currently have open recruitment for patients."
Answered by AI
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