Trial · NCT03832595
Kidney Coordinated Health Management Partnership
NCT03832595, Not applicable, Completed, University of Pittsburgh; results first posted 2024-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Kidney Coordinated Health Management Partnership. Trials, record NCT03832595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03832595
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Kidney Coordinated Health Management Partnership
- NCT number
- NCT03832595
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,596 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Chronic Kidney Diseases
- Interventions
- EHR-based PHM, Usual Care
- First posted
- 2019-02-06
- Last updated
- 2025-08-22
- Results first posted
- 2024-04-18
- Limitations and caveats
- Lower duration of follow-up period due to COVID-19 pandemic related delays
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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 approach using generalized linear mixed model. ESRD will be defined as an eGFR less than or equal to 10ml/min, or starting of renal replacement therapy (dialysis or kidney transplant) |
| Secondary | Hypertension (HTN) Control Outcome | 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 |
| Secondary | Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year | 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 |
| Secondary | Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year | 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 |
| Secondary | Medication Safety: Glyburide Exposure Days Per Year | 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 |
| Secondary | Medication Safety: Metformin Exposure Days Per Year | 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 |
| Secondary | Medication Safety: Gemfibrozil Exposure Days | Time to event analysis - Follow up duration until primary outcome or a competing event was achieved or until end of intervention period (max 39 months) | We will examine the rate of use of gemfibrozil among those with eGFR\<30 at baseline |
| Other | Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants With UACR ≥300 mg/g | 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). |
| Other | Hypertension (HTN) Control for Achieved BP <130/80 mm Hg | 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 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 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 | percent | NUMBER | |
| SECONDARY | Hypertension (HTN) Control Outcome | 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) | log-odds per month slope | LEAST_SQUARES_MEAN | |
| SECONDARY | Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year | 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) | exposure days per year | LEAST_SQUARES_MEAN | |
| SECONDARY | Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year | 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) | exposure days per year | LEAST_SQUARES_MEAN | |
| SECONDARY | Medication Safety: Glyburide Exposure Days Per Year | 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) | exposure days per year | LEAST_SQUARES_MEAN | |
| SECONDARY | Medication Safety: Metformin Exposure Days Per Year | 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) | exposure days per year | LEAST_SQUARES_MEAN | |
| SECONDARY | Medication Safety: Gemfibrozil Exposure Days | Time to event analysis - Follow up duration until primary outcome or a competing event was achieved or until end of intervention period (max 39 months) | Although Gemfibrozil was a pre-specified secondary outcome, it was excluded from analyses since among those with eGFR\<30 at baseline, active use was found only in 1 patient control arm) and there is no statistically meaningful way of analyzing this | ||
| OTHER_PRE_SPECIFIED | Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants With UACR ≥300 mg/g | 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) | medication exposure days per year | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Hypertension (HTN) Control for Achieved BP <130/80 mm Hg | 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) | log-odds per month slope | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Intervention Arm | 9.7 | 95% Confidence Interval 6.6 to 12.7 | percent | |
| 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) | Usual Care | 10.9 | 95% Confidence Interval 7.7 to 14.1 | percent | |
| Hypertension (HTN) Control Outcome | Intervention Arm | 0.011 | 95% Confidence Interval -0.002 to 0.024 | log-odds per month slope | |
| Hypertension (HTN) Control Outcome | Usual Care | 0.0005 | 95% Confidence Interval -0.012 to 0.013 | log-odds per month slope | |
| Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year | Intervention Arm | 196.8 | 95% Confidence Interval 174.9 to 219.0 | exposure days per year | |
| Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year | Usual Care | 163.1 | 95% Confidence Interval 146.3 to 179.9 | exposure days per year | |
| Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year | Intervention Arm | 5.3 | 95% Confidence Interval 2.6 to 8.0 | exposure days per year | |
| Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year | Usual Care | 6.7 | 95% Confidence Interval 3.7 to 9.7 | exposure days per year | |
| Medication Safety: Glyburide Exposure Days Per Year | Intervention Arm | 2.4 | 95% Confidence Interval -3.7 to 8.5 | exposure days per year | |
| Medication Safety: Glyburide Exposure Days Per Year | Usual Care | 2.0 | 95% Confidence Interval -1.6 to 5.7 | exposure days per year |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Arm | 754 | 48 |
| Overall Study | STARTED | Usual Care | 842 | 50 |
| Overall Study | COMPLETED | Intervention Arm | 575 | 48 |
| Overall Study | COMPLETED | Usual Care | 711 | 50 |
| Overall Study | NOT COMPLETED | Intervention Arm | 179 | 0 |
| Overall Study | NOT COMPLETED | Usual Care | 131 | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Moderate hyperkalemia (Serum potassium 5.5 - 6 meQ/L) | Renal and urinary disorders | Intervention Arm | 59 | 754 | 87 |
| other | Moderate hyperkalemia (Serum potassium 5.5 - 6 meQ/L) | Renal and urinary disorders | Usual Care | 77 | 842 | 107 |
| serious | Severe Hyperkalemia | Renal and urinary disorders | Intervention Arm | 18 | 754 | 23 |
| serious | Severe Hyperkalemia | Renal and urinary disorders | Usual Care | 21 | 842 | 28 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Arm | 142 | 754 |
| Total, all-cause mortality | Usual Care | 130 | 842 |
| Total, other adverse events | Intervention Arm | 59 | 754 |
| Total, other adverse events | Usual Care | 77 | 842 |
| Total, serious adverse events | Intervention Arm | 18 | 754 |
| Total, serious adverse events | Usual Care | 21 | 842 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01DK116957 | PopulAtioN health management to OPTImize Care in CKD (PANOPTIC-CKD) | ABDEL-KADER, KHALED A; JHAMB, MANISHA | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2018 to 2022 | NIH RePORTER |
| R18DK118460 | OPTIMIZing carE in Chronic Kidney Disease (OPTIMIZE CKD) | JHAMB, MANISHA | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2018 to 2020 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention Arm vs Usual Care: deaths from any cause | Trial comparisons |
| Intervention Arm vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03832595
GET https://conductscience.org/api/trials/v1/NCT03832595/registered