Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus

NCT07187479 | Recruiting

• 1 other identifier: AZ-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

chronic kidney disease; type 2 diabetes; diabetes; kidney disease

Outcome Measures

Primary Outcomes (4)

• Estimated Glomular Filtration Rate (eGFR)

  Assess the eGFR of patients in the PIR group as compared to the SOC group

  12 and 24 weeks

• Blood Urea Nitrogen/Creatinine Ratio (BUN/Cr)

  Assess the BUN/Cr of patients in the PIR group as compared to the SOC group

  12 and 24 weeks

• Cystatin C

  Assess the Cystatin C of patients in the PIR group as compared to the SOC group

  12 and 24 weeks

• Urine albumin-creatinine ratio (ACR)

  Assess the urine ACR of patients in the PIR group as compared to the SOC group

  12 and 24 weeks

Secondary Outcomes (9)

• Prescribed medication usage for control of symptoms

  12 and 24 weeks

• Hemoglobin A1c (HbA1c)

  12 and 24 weeks

• Fasting blood glucose

  12 and 24 weeks

• Fasting insulin level

  12 and 24 weeks

• HOMA-IR

  12 and 24 weeks

Study Arms (2)

Physiologic Insulin Resensitization (PIR) Group

EXPERIMENTAL

Subject to receive Physiologic Insulin Resensitization (PIR)

Other: Physiologic Insulin Resensitization (PIR)

Standard of Care (SOC) Group

NO INTERVENTION

Subjects will receive standard of care

Interventions

Physiologic Insulin Resensitization (PIR) OTHER

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

Physiologic Insulin Resensitization (PIR) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Well Cell Global: lead

Study Sites (1)

Arizona Kidney Disease and Hypertension Center

Phoenix, Arizona, 85027, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sungchun Lee, MD

  Arizona Kidney Disease and Hypertension Centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Marchase, PhD

CONTACT

205-612-4763; rmarchase@gmail.com

Samantha Villaverde

CONTACT

904-806-8280; samantha@wellcellglobal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Open Label Study

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 23, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)