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New treatment option for Chronic Kidney Disease (Stages 4 and 5)
Official title Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT07187479
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- In the opinion of the Investigator, has been on an appropriate, stable regimen for management of any complications present for the past six (6)...
- In the opinion of the Investigator, is able to do all of the following:
- Provide valid informed consent.
You likely can't join 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...
- 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
See the full eligibility 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...
- 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
- 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...
- Is on active dialysis at time of screening
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.