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SGLT2 Inhibitor

Patients and providers only aware of study eGFR values more than 25% below baseline for Kidney Transplant (START Trial)

Phase 2

Recruiting

Led By Martina M McGrath, MBBCh

Research Sponsored by Martina McGrath, MD

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 16 weeks total

Awards & highlights

START Trial Summary

This trialtests a drug's effects and safety on kidney transplant recipients to see if it can reverse changes in kidney function.

START Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks total

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks total

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks total for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reversibility of eGFR changes

Secondary outcome measures

Proportion of patients successfully completing the full treatment protocol, according to randomized groups

Other outcome measures

Safety Assessments

Tolerability Assessments

START Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients and providers only aware of study eGFR values more than 25% below baselineExperimental Treatment1 Intervention

Any study-related eGFR value more than 25% below the baseline measurement will be reported to the patient and treating physician.

Group II: Patients and providers aware of all study eGFR valuesExperimental Treatment1 Intervention

All study-related eGFR measurements will be reported to the treating physician and patient.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Martina McGrath, MDLead Sponsor

Brigham and Women's HospitalLead Sponsor

1,611 Previous Clinical Trials

11,470,469 Total Patients Enrolled

Martina M McGrath, MBBChPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Sotagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05405556 — Phase 2

Kidney Transplant Research Study Groups: Patients and providers only aware of study eGFR values more than 25% below baseline, Patients and providers aware of all study eGFR values

Kidney Transplant Clinical Trial 2023: Sotagliflozin Highlights & Side Effects. Trial Name: NCT05405556 — Phase 2

Sotagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05405556 — Phase 2

Frequently Asked Questions

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

Are there any openings for participants in this research?

"Affirmative. The information on clinicaltrials.gov demonstrates that recruitment for this medical trial is ongoing and began on October 17th 2022. Furthermore, the study was most recently updated five days later on October 22nd 2022 and is admitting 50 patients from a single medical centre."

Answered by AI

What is the enrollment capacity for this clinical research?

"Affirmative. According to the clinicaltrials.gov portal, this study is currently enrolling patients and was initially listed on October 17th 2022. The most recent alteration occurred on October 22nd of that same year, with a goal of 50 individuals at one medical site."

Answered by AI

Are both participants and healthcare providers cognizant of eGFR figures that are more than 25% lower than the starting value?

"Given the Phase 2 nature of this trial, with some safety data but no efficacy data currently available, our team has judged the potential safety of patients and providers being aware of eGFR values more than 25% below baseline to be a score 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients

Martina McGrath, MD 2022. "Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05405556.