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Intervention Arm for Chronic Kidney Disease (Kidney-CHAMP Trial)
N/A
Waitlist Available
Led By Khaled Abdel-Kader, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time to event analysis - until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months). cumulative % at 24 months reported
Awards & highlights
Summary
This trial will test whether an Electronic Health Record-based Population Health Management intervention can improve care for patients with high-risk Chronic Kidney Disease.
Eligible Conditions
- Chronic Kidney Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time to event analysis - until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months). cumulative % at 24 months reported
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time to event analysis - until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months). cumulative % at 24 months reported
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Renal Failure Event Defined as Greater Than or Equal to 40% Decline in Estimated Glomerular Filtration Rate (eGFR) or Occurrence of End Stage Renal Disease (ESRD)
Secondary outcome measures
Hypertension (HTN) Control Outcome
Medication Safety: Gemfibrozil Exposure Days
Medication Safety: Glyburide Exposure Days Per Year
+3 moreOther outcome measures
Subgroup Analysis Hypertension (HTN) Control (Outcome 2) in Participants With Uncontrolled BP at Baseline (i.e., BP >130/80 at Baseline).
Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants Who Are Baseline Non-users of RAASi
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Patients will receive a care bundle
Group II: Usual careActive Control1 Intervention
Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,737 Previous Clinical Trials
16,337,661 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
869 Previous Clinical Trials
677,028 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,313,506 Total Patients Enrolled
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