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

ConditionsChronic Kidney Disease(CKD)Type 2 DM Type 2 Diabetes Mellitus (T2DM)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(CKD Management)

Adults with type 2 diabetes (T2D)

Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)

UACR >300 mg/g or

Disqualifiers

(CKD Management)

Type 1 diabetes

Most recent eGFR <20 ml/min/1.73 m2

Prior kidney transplant

Trial design

Design model

Parallel

Treatments tested in this trial

(IRIS-CKD Management Program): Education
Other intervention
Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their Primary Care Provider (PCP). At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period.
(IRIS-CKD Management Program): GDMT
Other intervention
Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their PCP. At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period. Plus, receive guided care by APP.

Treatment groups

212 Participants

are divided into 2 treatment groups

Group A: (IRIS-CKD Management Program): EducationActive comparator 1 intervention

Group B: (IRIS-CKD Management Program): GDMTActive comparator 2 interventions

Trial outcomes

Primary outcomes

CKD GDMT Opportunity Score at 6 months

Opportunity score of GDMT prescriptions at 6 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 6 or the loss of an indication for the GDMT.

Time frame

6 months

Secondary outcomes

CKD GDMT Opportunity Score at 6 months weighted by dose

Change in opportunity score from baseline to 6 months weighted by prescribed dose of GDMT.

Time frame

6 months

CKD GDMT Opportunity Score at 3 months

Opportunity score of GDMT prescriptions at 3 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 3 or the loss of an indication for the GDMT.

Time frame

3 months

Other outcomes

UACR change

Change in UACR after 6 months

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Bayer

Collaborator

Boehringer Ingelheim

Collaborator

Source ClinicalTrials.gov

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