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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
No Placebo-Only Group
Summary
This trial tests a computerized system that helps doctors manage and improve care for patients with high-risk Chronic Kidney Disease. The system provides important health information and guidelines to ensure patients receive the best possible care. It aims to improve blood pressure control, use of specific medications, and avoid harmful drugs, ultimately slowing down CKD progression.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Hypertension (HTN) Control Outcome
Medication Safety: Gemfibrozil Exposure Days
Medication Safety: Glyburide Exposure Days Per Year
+3 moreOther study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,789 Previous Clinical Trials
16,358,027 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
902 Previous Clinical Trials
937,236 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,330,236 Total Patients Enrolled
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