Trial Outcomes & Findings for A Study to Examine Past Estimated Glomerular Filtration Rate (eGFR) Slope as a Risk Marker for Rapid Kidney Function Decline in People With Chronic Kidney Disease (NCT NCT04881448)

Last Updated: 2023-08-04

Results Overview

Retrospective and prospective slopes were derived using a linear random slope model. The prospective estimated Glomerular Filtration Rate (eGFR) slope for each patient was derived using eGFR values in the prospective phase as the dependent variable and time in the prospective phase as the continuous independent variable with random intercept and random slope. The retrospective eGFR slope for each patient was derived similarly using the data in the retrospective phase, and the time in the retrospective phase calculated relative to the first retrospective measurement per patient. Homogeneity was primarily evaluated via a shift analysis with categories of eGFR decline rate of 1 to \< 3 (slow) and \>= 3 ml/min/1.73m2/year (fast), in each of the retrospective and prospective phases. eGFR data collected 4 weeks before acute kidney injury and up to 8 weeks after acute kidney injury, and eGFR data occurring after changes to baseline background therapy (SGLT2i/ACEi/ARB) were excluded.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

223 participants

Primary outcome timeframe

Prospective slopes: All measurements from baseline until the last available visit were considered for inclusion in the estimation, including unscheduled visits, up to 48 weeks. Retrospective slopes: up to 66 months.

Results posted on

2023-08-04

Participant Flow

Multicentre, non-randomised, low-intervention study that did not involve administration of study drug, which aimed to investigate the estimated Glomerular Filtration Rate (eGRF) slopes derived from retrospective routine clinical practice data, compare those retrospective slopes with those generated in a prospective fashion and successively identify rapidly progressing chronic kidney disease (CKD) patients.

Patients were screened for eligibility prior to participation in the trial. They underwent a screening period of up to 2 weeks from the time of informed consent. Patients who successfully completed the screening and met all inclusion criteria, including the availability of requisite historical eGFR data, and did not meet any of the exclusion criteria, qualified for enrolment into the 48 weeks prospective phase of the study.

Participant milestones

Participant milestones
Measure	Patients With Chronic Kidney Disease - Overall Population Patients with chronic kidney disease (CKD), including patients with non-diabetic chronic kidney disease (non-DKD) and diabetic chronic kidney disease (DKD). This study did not involve administration of study drug.
Overall Study STARTED	223
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	223

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Chronic Kidney Disease - Overall Population Patients with chronic kidney disease (CKD), including patients with non-diabetic chronic kidney disease (non-DKD) and diabetic chronic kidney disease (DKD). This study did not involve administration of study drug.
Overall Study Study cancelled by sponsor	220
Overall Study Withdrawal by Subject	2
Overall Study Exhausted all attempts to contact subject	1

Baseline Characteristics

A Study to Examine Past Estimated Glomerular Filtration Rate (eGFR) Slope as a Risk Marker for Rapid Kidney Function Decline in People With Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Chronic Kidney Disease - Overall Population n=210 Participants Patients with chronic kidney disease (CKD), including patients with non-diabetic chronic kidney disease (non-DKD) and diabetic chronic kidney disease (DKD). This study did not involve administration of study drug.
Age, Continuous	68.2 Years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants
Sex: Female, Male Male	123 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	190 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	46 Participants n=5 Participants
Race (NIH/OMB) White	150 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prospective slopes: All measurements from baseline until the last available visit were considered for inclusion in the estimation, including unscheduled visits, up to 48 weeks. Retrospective slopes: up to 66 months.

Population: Full Analysis Set (FAS): FAS includes all patients entered into the 48-week prospective phase of the study who have at least one post-baseline assessment. Summary statistics are reported by overall and DKD/non-DKD patient populations. The n's in each category for DKD/non-DKD may not add up to the overall number, since separate random slope models are used leading to differences in estimated eGFR slope in each of the calculations.

Outcome measures

Outcome measures
Measure	Patients With Diabetic Chronic Kidney Disease - Patient Population n=114 Participants Patients with diabetic chronic kidney disease (DKD).	Patients With Non-diabetic Chronic Kidney Disease - Patient Population n=96 Participants Patients with non-diabetic chronic kidney disease (non-DKD).	Patients With Chronic Kidney Disease - Overall Population n=210 Participants Patients with chronic kidney disease (CKD), including patients with non-diabetic chronic kidney disease (non-DKD) and diabetic chronic kidney disease (DKD). This study did not involve administration of study drug.
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values from > -1 (in Retrospective Phase) to > -1 (in Prospective Phase)	4 Participants	8 Participants	9 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values from > -3 to -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase)	6 Participants	2 Participants	5 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values Retrospective Phase: > -1	9 Participants	15 Participants	21 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values Retrospective Phase: > -3 to -1	27 Participants	20 Participants	43 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values Retrospective Phase: <= -3	78 Participants	61 Participants	146 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values from > -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase)	1 Participants	1 Participants	2 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values from > -1 (in Retrospective Phase) to <= -3 (in Prospective Phase)	4 Participants	6 Participants	10 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values from > -3 to -1 (in Retrospective Phase) to > -1 (in Prospective Phase)	12 Participants	7 Participants	18 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values from > -3 to -1 (in Retrospective Phase) to <= -3 (in Prospective Phase)	9 Participants	11 Participants	20 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values from <= -3 (in Retrospective Phase) to > -1 (in Prospective Phase)	45 Participants	6 Participants	39 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values from <= -3 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase)	11 Participants	3 Participants	41 Participants
Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values from <= -3 (in Retrospective Phase) to <= -3 (in Prospective Phase)	22 Participants	52 Participants	66 Participants

Adverse Events

Patients With Chronic Kidney Disease - Overall Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Centre

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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Restriction type: OTHER