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TERMINATEDPHASE2

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

Evaluation of Homogeneity Between eGFR Slopes Derived From Retrospective Clinical Practice Data and eGFR Slopes Derived From Prospectively Collected, Protocol-driven Data

NCT04881448•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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).
+2 more criteria

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).

Locations (25)

Nephrology Consultants, LLC

Huntsville, Alabama, United States

Desert Cities Dialysis - Amethyst

Victorville, California, United States

Kidney & Hypertension Center

Victorville, California, United States

Davita Clinical Research-Hartford

Bloomfield, Connecticut, United States

Nephrology & Hypertension Assoc., PC

Middlebury, Connecticut, United States

Med-Care Research

Miami, Florida, United States

International Research Associates

Miami, Florida, United States

Columbus Regional Research Institute

Columbus, Georgia, United States

DaVita Clinical Research

Edina, Minnesota, United States

DaVita Clinical Research

Las Vegas, Nevada, United States

Key Dates

Start Date

September 16, 2021

Primary Completion Date

July 15, 2022

Completion Date

July 15, 2022

Last Updated

August 4, 2023

Enrollment

223

ACTUAL participants

Conditions

Chronic Kidney Disease

Interventions

collection of serum/capillary creatinine values

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

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