NCT07187479 Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
| NCT ID | NCT07187479 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Well Cell Global |
| Condition | Chronic Kidney Disease (Stages 4 and 5) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-10-14 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).
Eligibility Criteria
Inclusion Criteria: * Is age 18 or older (male or female) * Have a documented diagnosis of CKD stage 3b, 4, or 5 and T2DM of 6 months or greater prior to screening. Patients may have treatment regimens associated with T2DM that include diabetic oral and/or injectable medications including insulin and/or GLP-1 receptor agonists. * In the opinion of the Investigator, has been on an appropriate, stable regimen for management of any complications present for the past six (6) months. * In the opinion of the Investigator, is able to do all of the following: * Provide valid informed consent. * Understand and comply with study procedures as presented in the consent process. * Has the capacity or support to attend all required visits. * If female, the subject must meet either of the following sets of conditions: o Is of non-childbearing potential, defined as meeting either of the following criteria: * Age ≥50 years and post-menopausal for at least one (1) year * Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy * Is of childbearing potential and meets both of the following criteria: * Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening. * Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment Exclusion Criteria: * Has in the past two (2) years received treatment for a malignancy. * Current pregnancy or intends to become pregnant during the study * Has in the past one (1) year used non-prescription opioids or psychoactive drugs. * Has in the past six (6) months had a hypoglycemic event requiring urgent care and/or administration of glucagon, osteocalcin, or parenteral glucose, unless approved for enrollment by the Medical Monitor. * Has within the past one (1) month participated in a clinical study involving either of the following: * An investigational drug or procedure for any clinical indication * An investigation method for glucose control using approved agents * Is nursing or is planning to nurse during the study. * Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load. * Has at screening, one or more of the following abnormal lab results: * Hb \<8 g/dL * WBC \<2,000/µL * Platelets \<50,000/µL * ALT, AST, or Alkaline Phosphatase \>5x ULN * ALT or AST \>2.5x ULN, and Total Bilirubin \>2x ULN * Serum albumin \<3 g/dL * Has - in the opinion of the Investigator - psychiatric, behavioral, cognitive and/or clinical dysfunction (whether or not related to known medical illness or drug / alcohol use) that would affect the subject's safety and/or compliance. * Is on active dialysis at time of screening
Contact & Investigator
Sungchun Lee, MD
PRINCIPAL INVESTIGATOR
Arizona Kidney Disease and Hypertension Centers
Frequently Asked Questions
Who can join the NCT07187479 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Disease (Stages 4 and 5). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07187479 currently recruiting?
Yes, NCT07187479 is actively recruiting participants. Contact the research team at rmarchase@gmail.com for enrollment information.
Where is the NCT07187479 trial being conducted?
This trial is being conducted at Phoenix, United States.
Who is sponsoring the NCT07187479 clinical trial?
NCT07187479 is sponsored by Well Cell Global. The principal investigator is Sungchun Lee, MD at Arizona Kidney Disease and Hypertension Centers. The trial plans to enroll 120 participants.
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