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

• ClinicalTrials.gov Identifier: NCT04881448
• Recruitment Status: Terminated
• First Posted: May 11, 2021
• Results First Posted: August 4, 2023
• Last Update Posted: August 4, 2023
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Chronic Kidney Disease
• Intervention: Diagnostic Test: collection of serum/capillary creatinine values
• Enrollment: 223

Participant Flow

Recruitment Details

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.

Pre-assignment Details

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.

Arm/Group Title	Patients With Chronic Kidney Disease - Overall Population
Arm/Group Description	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.
Period Title: Overall Study
Started	223
Completed	0
Not Completed	223
Reason Not Completed
Study cancelled by sponsor	220
Withdrawal by Subject	2
Exhausted all attempts to contact subject	1

Baseline Characteristics

Arm/Group Title		Patients With Chronic Kidney Disease - Overall Population
Arm/Group Description		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 Number of Baseline Participants		210
Baseline Analysis Population Description		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.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	210 participants
		68.2 (10.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	210 participants
	Female	87 41.4%
	Male	123 58.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	210 participants
	Hispanic or Latino	20 9.5%
	Not Hispanic or Latino	190 90.5%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	210 participants
	American Indian or Alaska Native	0 0.0%
	Asian	4 1.9%
	Native Hawaiian or Other Pacific Islander	1 0.5%
	Black or African American	46 21.9%
	White	150 71.4%
	More than one race	1 0.5%
	Unknown or Not Reported	8 3.8%

Outcome Measures

1. Primary Outcome

Title	Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Patients With Diabetic Chronic Kidney Disease - Patient Population	Patients With Non-diabetic Chronic Kidney Disease - Patient Population	Patients With Chronic Kidney Disease - Overall Population
Arm/Group Description:		Patients with diabetic chronic kidney disease (DKD).	Patients with non-diabetic chronic kidney disease (non-DKD).	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 Number of Participants Analyzed		114	96	210
Measure Type: Count of Participants; Unit of Measure: Participants
Retrospective Phase: > -1	Number Analyzed	114 participants	96 participants	210 participants
		9 7.9%	15 15.6%	21 10.0%
Retrospective Phase: > -3 to -1	Number Analyzed	114 participants	96 participants	210 participants
		27 23.7%	20 20.8%	43 20.5%
Retrospective Phase: <= -3	Number Analyzed	114 participants	96 participants	210 participants
		78 68.4%	61 63.5%	146 69.5%
from > -1 (in Retrospective Phase) to > -1 (in Prospective Phase)	Number Analyzed	9 participants	15 participants	21 participants
		4 44.4%	8 53.3%	9 42.9%
from > -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase)	Number Analyzed	9 participants	15 participants	21 participants
		1 11.1%	1 6.7%	2 9.5%
from > -1 (in Retrospective Phase) to <= -3 (in Prospective Phase)	Number Analyzed	9 participants	15 participants	21 participants
		4 44.4%	6 40.0%	10 47.6%
from > -3 to -1 (in Retrospective Phase) to > -1 (in Prospective Phase)	Number Analyzed	27 participants	20 participants	43 participants
		12 44.4%	7 35.0%	18 41.9%
from > -3 to -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase)	Number Analyzed	27 participants	20 participants	43 participants
		6 22.2%	2 10.0%	5 11.6%
from > -3 to -1 (in Retrospective Phase) to <= -3 (in Prospective Phase)	Number Analyzed	27 participants	20 participants	43 participants
		9 33.3%	11 55.0%	20 46.5%
from <= -3 (in Retrospective Phase) to > -1 (in Prospective Phase)	Number Analyzed	78 participants	61 participants	146 participants
		45 57.7%	6 9.8%	39 26.7%
from <= -3 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase)	Number Analyzed	78 participants	61 participants	146 participants
		11 14.1%	3 4.9%	41 28.1%
from <= -3 (in Retrospective Phase) to <= -3 (in Prospective Phase)	Number Analyzed	78 participants	61 participants	146 participants
		22 28.2%	52 85.2%	66 45.2%

Adverse Events

Time Frame	From signing the informed consent onwards until the end of study visit, up to 50 weeks.
Adverse Event Reporting Description	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.
Arm/Group Title	Patients With Chronic Kidney Disease - Overall Population
Arm/Group Description	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.
All-Cause Mortality
	Patients With Chronic Kidney Disease - Overall Population
	Affected / at Risk (%)
Total	0/210 (0.00%)
Serious Adverse Events
	Patients With Chronic Kidney Disease - Overall Population
	Affected / at Risk (%)
Total	0/210 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Patients With Chronic Kidney Disease - Overall Population
	Affected / at Risk (%)
Total	0/210 (0.00%)

Limitations and Caveats

The study was terminated prematurely, due to decision of the sponsor. Due to the early study termination leading to a short follow up time and limited number of eGFR assessments in the prospective phase, the results need to be interpreted cautiously.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim
• Phone: 1-800-243-0127
• EMail: clintriage.rdg@boehringer-ingelheim.com

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT04881448
• Other Study ID Numbers: 1366-0026
• First Submitted: May 4, 2021
• First Posted: May 11, 2021
• Results First Submitted: July 14, 2023
• Results First Posted: August 4, 2023
• Last Update Posted: August 4, 2023