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

NCT04881448 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 1366-0026
• Study Type: interventional
• Target: 223
• Locations: 4 countries
• Sites: 25

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (1)

Patients with chronic kidney disease - overall population

EXPERIMENTAL

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.

Diagnostic Test: collection of serum/capillary creatinine values

Interventions

collection of serum/capillary creatinine values DIAGNOSTIC_TEST

collection of serum/capillary creatinine values

Patients with chronic kidney disease - overall population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (25)

Nephrology Consultants, LLC

Huntsville, Alabama, 35805, United States

Location

Desert Cities Dialysis - Amethyst

Victorville, California, 92392, United States

Location

Kidney & Hypertension Center

Victorville, California, 92395, United States

Location

Davita Clinical Research-Hartford

Bloomfield, Connecticut, 06002, United States

Location

Nephrology & Hypertension Assoc., PC

Middlebury, Connecticut, 06762-2843, United States

Location

Med-Care Research

Miami, Florida, 33125, United States

Location

International Research Associates

Miami, Florida, 33183, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

DaVita Clinical Research

Edina, Minnesota, 55435-2129, United States

Location

DaVita Clinical Research

Las Vegas, Nevada, 89128, United States

Location

Kidney Medical Associates, PLLC

The Bronx, New York, 10461, United States

Location

DaVita Clinical Research (DCR) Spartanburg

Spartanburg, South Carolina, 29306, United States

Location

Davita Clinical Research

El Paso, Texas, 79925, United States

Location

Sunbeam Clinical Research

Greenville, Texas, 75402-6004, United States

Location

DaVita Clinical Research

Houston, Texas, 77054, United States

Location

DaVita Clinical Research

San Antonio, Texas, 78251, United States

Location

DaVita Clinical Research

The Woodlands, Texas, 77384, United States

Location

Tidewater Kidney Specialists

Chesapeake, Virginia, 23320, United States

Location

DaVita Clinical Research

Wauwatosa, Wisconsin, 53226, United States

Location

DaVita Clinical Research Germany GmbH

Düsseldorf, 40210, Germany

Location

InnoDiab Forschung GmbH

Essen, 45136, Germany

Location

DaVita Clinical Research Germany GmbH

Geilenkirchen, 52511, Germany

Location

DRC Drug Research Ltd

Balatonfüred, 8230, Hungary

Location

Szent Imre Korhaz, Budapest

Budapest, 1115, Hungary

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 11, 2021
• Study Start: September 16, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: August 4, 2023
• Results First Posted: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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'.

Locations

US (19); DE (3); ES (1); HU (2)