Clinical trial NCT04881448: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants, LLC
state: Alabama
city: Victorville
country: United States
facility: Desert Cities Dialysis - Amethyst
state: California
city: Victorville
country: United States
facility: Kidney & Hypertension Center
state: California
city: Bloomfield
country: United States
facility: Davita Clinical Research-Hartford
state: Connecticut
city: Middlebury
country: United States
facility: Nephrology & Hypertension Assoc., PC
state: Connecticut
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Miami
country: United States
facility: International Research Associates
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Edina
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: Las Vegas
country: United States
facility: DaVita Clinical Research
state: Nevada
city: Bronx
country: United States
facility: Kidney Medical Associates, PLLC
state: New York
city: Spartanburg
country: United States
facility: DaVita Clinical Research (DCR) Spartanburg
state: South Carolina
city: El Paso
country: United States
facility: Davita Clinical Research
state: Texas
city: Greenville
country: United States
facility: Sunbeam Clinical Research
state: Texas
city: Houston
country: United States
facility: DaVita Clinical Research
state: Texas
city: San Antonio
country: United States
facility: DaVita Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: DaVita Clinical Research
state: Texas
city: Chesapeake
country: United States
facility: Tidewater Kidney Specialists
state: Virginia
city: Wauwatosa
country: United States
facility: DaVita Clinical Research
state: Wisconsin
city: Düsseldorf
country: Germany
facility: DaVita Clinical Research Germany GmbH
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Geilenkirchen
country: Germany
facility: DaVita Clinical Research Germany GmbH
city: Balatonfured
country: Hungary
facility: DRC Drug Research Ltd
city: Budapest
country: Hungary
facility: Szent Imre Korhaz, Budapest
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
Study officials:
References: