Chronic Kidney Disease (Stages 4 and 5)NCT07187479
Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
A study testing Physiologic Insulin Resensitization (PIR) in people with Chronic Kidney Disease (Stages 4 and 5) and Kidney Disease, run by Well Cell Global at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stages 4 and 5), Kidney Disease, Type 2 Diabetes
- What is being tested?
- Physiologic Insulin Resensitization (PIR)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85027
Cynthia Carrizoza, MS, CCRP, 602-997-0484, ccarrizoza@akdhc.com
Sungchun Lee, MD
- Recruiting
Innovative Diabetic Center
Scottsdale, Arizona, 85258
Austin Mill, ACNP-BC, 480-493-0900, austin.mill@getinnovative.care
Nezar Dahdal, MD
About this study
Official title: Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
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).
Read the detailed description
The primary objective of this study is to assess the outcomes of Physiologic Insulin Resensitization (PIR) treatment compared to standard of care (SOC) on renal patients with a diagnosis of chronic kidney disease (CKD) (stages 3b, 4 and 5) and Type 2 diabetes mellitus (T2DM)
- Being tested
- Physiologic Insulin Resensitization (PIR)
- Keywords
- chronic kidney disease, type 2 diabetes, diabetes, kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiologic Insulin Resensitization (PIR)Other
PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Physiologic Insulin Resensitization (PIR) Group | Experimental | Subject to receive Physiologic Insulin Resensitization (PIR) Receives: Other: Physiologic Insulin Resensitization (PIR) |
| Standard of Care (SOC) Group | No intervention | Subjects will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Glomular Filtration Rate (eGFR)
Assess the eGFR of patients in the PIR group as compared to the SOC group
Measured: 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
Measured: 12 and 24 weeks
Cystatin C
Assess the Cystatin C of patients in the PIR group as compared to the SOC group
Measured: 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
Measured: 12 and 24 weeks
Secondary outcomes (9)
Prescribed medication usage for control of symptoms
Assess changes of medications in the PIR group as compared to the SOC group
Measured: 12 and 24 weeks
Hemoglobin A1c (HbA1c)
Assess the Hb1c of patients in the PIR group as compared to the SOC group
Measured: 12 and 24 weeks
Fasting blood glucose
Assess the fasting blood glucose of patients in the PIR group as compared to the SOC group
Measured: 12 and 24 weeks
Fasting insulin level
Assess the fasting insulin level of patients in the PIR group as compared to the SOC group
Measured: 12 and 24 weeks
HOMA-IR
Assess the HOMA-IR of patients in the PIR group as compared to the SOC group
Measured: 12 and 24 weeks
Blood Pressure
Assess the Blood Pressure of patients in the PIR group as compared to the SOC group
Measured: 12 and 24 weeks
Lipid profile
Assess the Lipid Profile of patients in the PIR group as compared to the SOC group
Measured: 12 and 24 weeks
C peptide
Assess the C peptide of patients in the PIR group as compared to the SOC group
Measured: 12 and 24 weeks
EQ-5D-5L Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire)
Assess the Quality of Life of patients in the PIR group as compared to the SOC group. Lower health index scores reflect greater health deficits.
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start14 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stages 4 and 5)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Open Label Study
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Well Cell Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sungchun Lee, MD, Principal investigator, Arizona Kidney Disease and Hypertension Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187479
- Sponsor's protocol ID
- AZ-01
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing plan is to be determined.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07187479
- Acronym / sponsor ID
- AZ-01
- Keywords
- chronic kidney disease, type 2 diabetes, diabetes, kidney disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Well Cell GlobalIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The primary objective of this study is to assess the outcomes of Physiologic Insulin Resensitization (PIR) treatment compared to standard of care (SOC) on renal patients with a diagnosis of chronic kidney disease (CKD) (stages 3b, 4 and 5) and Type 2 diabetes mellitus (T2DM)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open Label Study
| Arm | Type | Receives |
|---|---|---|
| Physiologic Insulin Resensitization (PIR) Group | Experimental | Other: Physiologic Insulin Resensitization (PIR)Subject to receive Physiologic Insulin Resensitization (PIR) |
| Standard of Care (SOC) Group | No intervention | –Subjects will receive standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- If female, the subject must meet either of the following sets of conditions:
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiologic Insulin Resensitization (PIR)PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously. | Other | Physiologic Insulin Resensitization (PIR) Group |
Primary outcome
Estimated Glomular Filtration Rate (eGFR)
Time frame: 12 and 24 weeks
Assess the eGFR of patients in the PIR group as compared to the SOC group
Blood Urea Nitrogen/Creatinine Ratio (BUN/Cr)
Time frame: 12 and 24 weeks
Assess the BUN/Cr of patients in the PIR group as compared to the SOC group
Cystatin C
Time frame: 12 and 24 weeks
Assess the Cystatin C of patients in the PIR group as compared to the SOC group
Urine albumin-creatinine ratio (ACR)
Time frame: 12 and 24 weeks
Assess the urine ACR of patients in the PIR group as compared to the SOC group
9 secondary outcomes
Prescribed medication usage for control of symptoms
Time frame: 12 and 24 weeks
Hemoglobin A1c (HbA1c)
Time frame: 12 and 24 weeks
Fasting blood glucose
Time frame: 12 and 24 weeks
Fasting insulin level
Time frame: 12 and 24 weeks
HOMA-IR
Time frame: 12 and 24 weeks
Blood Pressure
Time frame: 12 and 24 weeks
Lipid profile
Time frame: 12 and 24 weeks
C peptide
Time frame: 12 and 24 weeks
EQ-5D-5L Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire)
Time frame: 12 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided. Data sharing plan is to be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sungchun Lee, MD principal investigator
Arizona Kidney Disease and Hypertension Centers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiologic Insulin Resensitization (PIR) in people with Chronic Kidney Disease (Stages 4 and 5) and Kidney Disease, run by Well Cell Global at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Marchase, PhD (205-612-4763, rmarchase@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Glomular Filtration Rate (eGFR) (time frame: 12 and 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.