NCT04616612Completed
Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study
Source: ClinicalTrials.gov · Last updated 23 Apr 2025
Brief summary (registry, in English)
The purpose of this 2-group, randomized, controlled trial is to evaluate the refined SystemCHANGE™ against attention control patient education in CKD patients taking RAAS medications.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 17 Sept 2020
- Start date
- 15 Dec 2021
- Primary completion date
- 6 Feb 2024
- Lead sponsor
- Indiana University
- Diseases
- Chronic kidney disease
- NCT number
- NCT04616612
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From 15 Dec 2021 to the primary completion date, 6 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants will be excluded if they are receiving dialysis or have dialysis access placed (e.g. graft or arteriovenous fistula) in anticipation of starting dialysis.
- Kidney and kidney-pancreas transplant recipients will be excluded.
Lab values
- Participants with kidney failure defined by GFR \<15 mL/min/1.73
Who the study is looking for
- age \> 18 years
- prescribed at least 1 daily RAAS inhibiting medication
- CKD diagnosis estimated glomerular filtration rate (eGFR) category G1 to G4
- RAAS inhibiting medication adherence of \<.85 documented during the screening phase
- proteinuria defined as a urine Protein-to-Creatinine ratio \> 150 mg/g or urine Albumin-to-Creatinine ratio \>30mg/g
- able to speak, hear, and understand English determined by the ability to participate and comprehend conversation about potential inclusion in the study
- self-reported ability to open a pill cap
- able to self-administer RAAS inhibiting medications
- willing to use a study phone
- has no cognitive impairment as determined by a score of 4 or greater on the 6-item Telephone Mental Status Screen Derived from the Mini-Mental Status Exam (cognitive screener)
- has no other diagnoses that may shorten life span, such as metastatic cancer
- is not currently hospitalized
- receives care through two approved health care systems
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University School of Nursing Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.