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Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

IRIS-CKD studies a program to improve testing and recommended care for chronic kidney disease, or long-term kidney damage. This part of the study is for adults in the United States who have type 2 diabetes and kidney disease.

IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult with type 2 diabetes.
  • You had a primary care visit within the study’s health system in the past 24 months.
  • Kidney tests from the past 2 years show one of these: UACR above 300, eGFR below 45, or UACR at least 30 with eGFR below 60. UACR measures protein in urine (mg/g). eGFR estimates how well your kidneys filter blood (ml/min/1.73 m²).
  • If your kidney tests were not done within 3 months before joining, the results must be confirmed during screening.
  • You are not yet receiving all recommended kidney medicines that are safe for you. If your UACR is below 30, this means an SGLT2 inhibitor. For other eligible patients, it means an ACE inhibitor or ARB, an SGLT2 inhibitor, and finerenone.

Who can't join

  • You have type 1 diabetes.
  • Your latest eGFR, a measure of kidney filtering, is below 20 ml/min/1.73 m².
  • You have had a kidney transplant.
  • You have autosomal dominant polycystic kidney disease (ADPKD), an inherited disease that causes fluid-filled sacs in the kidneys.
  • You are pregnant or plan to become pregnant within 1 year.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * (CKD Management) * Adults with type 2 diabetes (T2D) * Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP) * Evidence of CKD based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment): * UACR \>300 mg/g or * eGFR \<45 ml/min/1.73 m2 or * UACR ≥30 mg/g with eGFR \<60 ml/min/1.73 m2 * Receiving \<100% GDMT at baseline. For patients with UACR \<30 mg/g, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.). Exclusion Criteria: * (CKD Management) * Type 1 diabetes * Most recent eGFR \<20 ml/min/1.73 m2 * Prior kidney transplant * Autosomal dominant polycystic kidney disease (ADPKD) * Active pregnancy or plans for conception within 1 year

Study sites (7)

AL

FL

MI

MN

NC

TX