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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

Primary Purpose

Chronic Kidney Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
collection of serum/capillary creatinine values
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Manufacturing Practice (ICH-GCP) and local legislation prior to admission to the trial.
  2. Patients with available medical records for data abstraction to meet the objectives of the study.
  3. Male or female patients aged ≥ 18 years at time of consent.
  4. Body Mass Index (BMI) ≥ 18.5 and < 50 kg/m² at Visit 1.
  5. Clinical diagnosis of Chronic Kidney Disease (CKD).
  6. Estimated Glomerular Filtration Rate (eGFR) decline of at least 1ml/min/1.73m²/year based on historical data from (electronic) medical records.
  7. eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) 20 - 90 ml/min/1.73m² at Visit 1 calculated from serum creatinine measured by a central laboratory.
  8. Patients are expected to be on optimal and stable background treatment (according to local therapy guidelines).

  9. At least 4 serum creatinine values in the retrospective phase:

    • The most recent creatinine value not more than 6 months prior to Visit 1 (Screening Visit).
    • The most recent and oldest serum creatinine values should be no less than 1 year apart and no greater than 5 years apart.
    • There should be no gap of creatinine values of 2 years or longer.

Exclusion Criteria:

  1. Changes in CKD or other key background treatments (including dose changes) known to impact eGFR values, over the past 4 weeks for Angiotensin Converting Enzyme inhibitors (ACEis) and Angiotensin Receptor Blockers (ARBs) and 8 weeks for Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors prior to Screening.
  2. Autosomal Dominant Polycystic Kidney Disease (ADPKD), uncontrolled lupus nephritis, in the opinion of investigators.
  3. Any iv immune suppression therapy within the last 3 months prior to Visit 1 or anyone currently on >45 mg prednisolone (or equivalent).
  4. Acute kidney injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition in the 30 days prior to Visit 1 until the start of trial assessments.
  5. Planned start of chronic renal replacement therapy during the trial or end stage renal disease (i.e < 15 ml/min at 2 measurements 30 days apart) before start of trial assessments.
  6. Medical history of cancer or treatment for cancer in the last two years prior to Visit 1 (except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, and prostatic cancer of low grade [T1 or T2]).
  7. Major surgery (investigator's judgement) planned during the trial.
  8. Currently enrolled in an investigational device or drug trial, i.e., less than 30 days before Visit 1 since ending an investigational device or drug trial(s) or receiving investigational treatment(s).

Further exclusion criteria apply.

Sites / Locations

  • Nephrology Consultants, LLC
  • Desert Cities Dialysis - Amethyst
  • Kidney & Hypertension Center
  • Davita Clinical Research-Hartford
  • Nephrology & Hypertension Assoc., PC
  • Med-Care Research
  • International Research Associates
  • Columbus Regional Research Institute
  • DaVita Clinical Research
  • DaVita Clinical Research
  • Kidney Medical Associates, PLLC
  • DaVita Clinical Research (DCR) Spartanburg
  • Davita Clinical Research
  • Sunbeam Clinical Research
  • DaVita Clinical Research
  • DaVita Clinical Research
  • DaVita Clinical Research
  • Tidewater Kidney Specialists
  • DaVita Clinical Research
  • DaVita Clinical Research Germany GmbH
  • InnoDiab Forschung GmbH
  • DaVita Clinical Research Germany GmbH
  • DRC Drug Research Ltd
  • Szent Imre Korhaz, Budapest
  • Hospital Virgen Macarena

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with chronic kidney disease - overall population

Arm Description

Patients with chronic kidney disease (CKD), including patients with non-diabetic chronic kidney disease (non-DKD) and diabetic kidney disease (DKD). Participants in this study did not receive any medication or study drug.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 4, 2021
Last Updated
July 14, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04881448
Brief Title
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
Official Title
Evaluation of Homogeneity Between eGFR Slopes Derived From Retrospective Clinical Practice Data and eGFR Slopes Derived From Prospectively Collected, Protocol-driven Data
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment challenges
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is intended to investigate the usefulness of estimated glomerular filtration rate (eGFR) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with chronic kidney disease - overall population
Arm Type
Experimental
Arm Description
Patients with chronic kidney disease (CKD), including patients with non-diabetic chronic kidney disease (non-DKD) and diabetic kidney disease (DKD). Participants in this study did not receive any medication or study drug.
Intervention Type
Diagnostic Test
Intervention Name(s)
collection of serum/capillary creatinine values
Intervention Description
collection of serum/capillary creatinine values
Primary Outcome Measure Information:
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Manufacturing Practice (ICH-GCP) and local legislation prior to admission to the trial. Patients with available medical records for data abstraction to meet the objectives of the study. Male or female patients aged ≥ 18 years at time of consent. Body Mass Index (BMI) ≥ 18.5 and < 50 kg/m² at Visit 1. Clinical diagnosis of Chronic Kidney Disease (CKD). Estimated Glomerular Filtration Rate (eGFR) decline of at least 1ml/min/1.73m²/year based on historical data from (electronic) medical records. eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) 20 - 90 ml/min/1.73m² at Visit 1 calculated from serum creatinine measured by a central laboratory. Patients are expected to be on optimal and stable background treatment (according to local therapy guidelines). At least 4 serum creatinine values in the retrospective phase: The most recent creatinine value not more than 6 months prior to Visit 1 (Screening Visit). The most recent and oldest serum creatinine values should be no less than 1 year apart and no greater than 5 years apart. There should be no gap of creatinine values of 2 years or longer. Exclusion Criteria: Changes in CKD or other key background treatments (including dose changes) known to impact eGFR values, over the past 4 weeks for Angiotensin Converting Enzyme inhibitors (ACEis) and Angiotensin Receptor Blockers (ARBs) and 8 weeks for Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors prior to Screening. Autosomal Dominant Polycystic Kidney Disease (ADPKD), uncontrolled lupus nephritis, in the opinion of investigators. Any iv immune suppression therapy within the last 3 months prior to Visit 1 or anyone currently on >45 mg prednisolone (or equivalent). Acute kidney injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition in the 30 days prior to Visit 1 until the start of trial assessments. Planned start of chronic renal replacement therapy during the trial or end stage renal disease (i.e < 15 ml/min at 2 measurements 30 days apart) before start of trial assessments. Medical history of cancer or treatment for cancer in the last two years prior to Visit 1 (except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, and prostatic cancer of low grade [T1 or T2]). Major surgery (investigator's judgement) planned during the trial. Currently enrolled in an investigational device or drug trial, i.e., less than 30 days before Visit 1 since ending an investigational device or drug trial(s) or receiving investigational treatment(s). Further exclusion criteria apply.
Facility Information:
Facility Name
Nephrology Consultants, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Desert Cities Dialysis - Amethyst
City
Victorville
State/Province
California
ZIP/Postal Code
92392
Country
United States
Facility Name
Kidney & Hypertension Center
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
Davita Clinical Research-Hartford
City
Bloomfield
State/Province
Connecticut
ZIP/Postal Code
06002
Country
United States
Facility Name
Nephrology & Hypertension Assoc., PC
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762-2843
Country
United States
Facility Name
Med-Care Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
International Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
DaVita Clinical Research
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435-2129
Country
United States
Facility Name
DaVita Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Kidney Medical Associates, PLLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
DaVita Clinical Research (DCR) Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29306
Country
United States
Facility Name
Davita Clinical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
Sunbeam Clinical Research
City
Greenville
State/Province
Texas
ZIP/Postal Code
75402-6004
Country
United States
Facility Name
DaVita Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
DaVita Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
DaVita Clinical Research
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Tidewater Kidney Specialists
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
DaVita Clinical Research
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
DaVita Clinical Research Germany GmbH
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
InnoDiab Forschung GmbH
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
DaVita Clinical Research Germany GmbH
City
Geilenkirchen
ZIP/Postal Code
52511
Country
Germany
Facility Name
DRC Drug Research Ltd
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Szent Imre Korhaz, Budapest
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

Learn more about this trial

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

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