NCT03832595: Kidney-CHAMP

Kidney Coordinated Health Management Partnership

Completed NA Results posted Last updated 22 August 2025

What this trial tests

NA trial testing EHR-based PHM in Chronic Kidney Diseases in 1,596 participants. Completed in 31 July 2023.

Timeline

1 May 2019

Primary endpoint
31 July 2022

31 July 2023

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1,596
Start date	1 May 2019
Primary completion	31 July 2022
Estimated completion	31 July 2023
Sites	1 location across United States

Drugs / interventions tested

• EHR-based PHM
• Usual Care

Conditions studied

• Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →

Sponsor

University of Pittsburgh

Who can join

Adults 18 to 85, any sex, with Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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

The outcome measure is occurrence of renal failure event and is defined as a greater than or equal to 40% decline in eGFR or occurrence of End Stage Renal Disease. The 40% decline in renal failure is a well accepted endpoint for renal failure in clinical trials and is approved by the FDA. eGFR decline will be adjudicated based on the baseline creatinine and eGFR determined from the CKD-epidemiology (CKD-EPI) equation and measured routinely in clinical practice. All eGFR values within 6-month windows will be averaged to account for ascertainment bias, and analyzed using discrete-time survival

Group	Value	95% CI
Intervention Arm	9.7	6.6 – 12.7
Usual Care	10.9	7.7 – 14.1

Hypertension (HTN) Control Outcome Secondary · 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)

HTN control is defined as achieved BP\<140/90mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control

Group	Value	95% CI
Intervention Arm	0.011	-0.002 – 0.024
Usual Care	0.0005	-0.012 – 0.013

Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year Secondary · Time to event analysis- Follow-up duration 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)

Will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as exposure days per year rate for each arm

Group	Value	95% CI
Intervention Arm	196.8	174.9 – 219.0
Usual Care	163.1	146.3 – 179.9

Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year Secondary · Time to event analysis- Follow-up duration 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)

Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as exposure days per year rate for each arm NSAIDS use will be examined for all study patients

Group	Value	95% CI
Intervention Arm	5.3	2.6 – 8.0
Usual Care	6.7	3.7 – 9.7

Medication Safety: Glyburide Exposure Days Per Year Secondary · Time to event analysis - Follow-up duration 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)

Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as Exposure days per year rate for each arm Glyburide use will be examined for all study patients with diabetes at baseline

Group	Value	95% CI
Intervention Arm	2.4	-3.7 – 8.5
Usual Care	2.0	-1.6 – 5.7

Medication Safety: Metformin Exposure Days Per Year Secondary · Time to event analysis- Follow-up duration 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)

Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as Exposure days per year rate for each arm Use of metformin will be examined for all study patients with diabetes at baseline and eGFR less than 30

Group	Value	95% CI
Intervention Arm	17.8	-6.5 – 42.2
Usual Care	16.0	-1.7 – 33.6

Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants With UACR ≥300 mg/g Secondary · Time to event analysis- Follow-up duration 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)

Outcome 3 will be repeated in the subgroup of participants receiving RAASi who have macroalbuminuria, RAASi use will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).

Group	Value	95% CI
Usual Care	177.5	146.2 – 208.8
Intervention Arm	222.5	182.9 – 262.1

Hypertension (HTN) Control for Achieved BP <130/80 mm Hg Secondary · Time to event analysis- Follow-up duration 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)

HTN control is defined as achieved BP\<130/80mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control

Group	Value	95% CI
Intervention Arm	0.086	0.073 – 0.100
Usual Care	0.079	0.066 – 0.092

Adverse events — posted to ClinicalTrials.gov

Time frame: Over the entire study follow-up period, median follow-up 17 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Arm

Serious: 18/754 (2%)

Deaths: 142/754

Usual Care

Serious: 21/842 (2%)

Deaths: 130/842

Serious adverse events (1 terms)

Reaction	System	Intervention Arm	Usual Care
Severe Hyperkalemia	Renal and urinary disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention Arm	Usual Care
Moderate hyperkalemia (Serum potassium 5.5 - 6 meQ/L)	Renal and urinary disorders	—	—

Most-reported serious reactions: Severe Hyperkalemia.

Data from ClinicalTrials.gov NCT03832595 adverse events section.

Sponsor's own description

As part of a 42-month pragmatic, cluster randomized trial in 1,650 primary care patients with high-risk Chronic Kidney Disease (CKD), the investigators will test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM) intervention that targets improvements in the delivery of evidence-based CKD care.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Electronic Health Record Population Health Management for Chronic Kidney Disease Care: A Cluster Randomized Clinical Trial.
   Jhamb M, Weltman MR, Devaraj SM, Lavenburg LU, et al · · 2024 · cited 24× · PMID 38619824 · DOI 10.1001/jamainternmed.2024.0708
2. Electronic health record based population health management to optimize care in CKD: Design of the Kidney Coordinated HeAlth Management Partnership (K-CHAMP) trial.
   Jhamb M, Weltman MR, Yabes JG, Kamat S, et al · · 2023 · cited 13× · PMID 37348600 · DOI 10.1016/j.cct.2023.107269
3. EHR-Based Clinical Trials: The Next Generation of Evidence.
   Abdel-Kader K, Jhamb M. · · 2020 · cited 10× · PMID 32094245 · DOI 10.2215/cjn.11860919
4. Population Health Management and Guideline-Concordant Care in CKD: A Secondary Analysis of Kidney Coordinated HeAlth Management Partnership.
   Weltman MR, Lavenburg LU, Han Z, Alghwiri AA, et al · · 2025 · cited 8× · PMID 39485493 · DOI 10.1681/asn.0000000544
5. Effect of a Population Health Management Intervention on Medication Therapy Problems in People With Chronic Kidney Disease: Post Hoc Analysis of the K-CHAMP Cluster-Randomized Trial.
   Weltman MR, Han Z, Lavenburg LU, Alghwiri AA, et al · · 2025 · cited 3× · PMID 40330910 · DOI 10.1016/j.xkme.2025.100995