Recruiting

PIR

Sponsor:

Well Cell Global

Code:

NCT07187479

Conditions

Chronic Kidney Disease (Stages 4 and 5)

Kidney Disease

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physiologic Insulin Resensitization (PIR)

Study Details

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).

Conditions

Chronic Kidney Disease (Stages 4 and 5)

Kidney Disease

Type 2 Diabetes

Study ID

NCT07187479

Start date

Oct 14, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Physiologic Insulin Resensitization (PIR) Group

Subject to receive Physiologic Insulin Resensitization (PIR)

no intervention: Standard of Care (SOC) Group

Subjects will receive standard of care

Interventions

Physiologic Insulin Resensitization (PIR)

PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.

Primary outcome measure

  • Estimated Glomular Filtration Rate (eGFR) [ Time Frame: 12 and 24 weeks ]
  • Blood Urea Nitrogen/Creatinine Ratio (BUN/Cr) [ Time Frame: 12 and 24 weeks ]
  • Cystatin C [ Time Frame: 12 and 24 weeks ]
  • Urine albumin-creatinine ratio (ACR) [ Time Frame: 12 and 24 weeks ]

Central Contacts and Locations

Central contacts

Richard Marchase, PhD

205-612-4763rmarchase@gmail.com

Samantha Villaverde

904-806-8280samantha@wellcellglobal.com

Locations

Arizona Kidney Disease and Hypertension Center

Recruiting

Phoenix, Arizona, United States, 85027

Contacts

Cynthia Carrizoza, MS, CCRP

602-997-0484ccarrizoza@akdhc.com

Principal Investigator:

Sungchun Lee, MD

Innovative Diabetic Center

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Austin Mill, ACNP-BC

480-493-0900austin.mill@getinnovative.care

Principal Investigator:

Nezar Dahdal, MD

More Information

Sponsor

Well Cell Global

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

  • chronic kidney disease
  • type 2 diabetes
  • diabetes
  • kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Well Cell Global on 2026-08-04.