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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04881448
• Other study ID #: 1366-0026
• Status: Terminated
• Phase: Phase 2
• Start date: September 16, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 223
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• collection of serum/capillary creatinine values
collection of serum/capillary creatinine values

Locations

Country	Name	City	State
Germany	DaVita Clinical Research Germany GmbH	Düsseldorf
Germany	InnoDiab Forschung GmbH	Essen
Germany	DaVita Clinical Research Germany GmbH	Geilenkirchen
Hungary	DRC Drug Research Ltd	Balatonfured
Hungary	Szent Imre Korhaz, Budapest	Budapest
Spain	Hospital Virgen Macarena	Sevilla
United States	Davita Clinical Research-Hartford	Bloomfield	Connecticut
United States	Kidney Medical Associates, PLLC	Bronx	New York
United States	Tidewater Kidney Specialists	Chesapeake	Virginia
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	DaVita Clinical Research	Edina	Minnesota
United States	Davita Clinical Research	El Paso	Texas
United States	Sunbeam Clinical Research	Greenville	Texas
United States	DaVita Clinical Research	Houston	Texas
United States	Nephrology Consultants, LLC	Huntsville	Alabama
United States	DaVita Clinical Research	Las Vegas	Nevada
United States	International Research Associates	Miami	Florida
United States	Med-Care Research	Miami	Florida
United States	Nephrology & Hypertension Assoc., PC	Middlebury	Connecticut
United States	DaVita Clinical Research	San Antonio	Texas
United States	DaVita Clinical Research (DCR) Spartanburg	Spartanburg	South Carolina
United States	DaVita Clinical Research	The Woodlands	Texas
United States	Desert Cities Dialysis - Amethyst	Victorville	California
United States	Kidney & Hypertension Center	Victorville	California
United States	DaVita Clinical Research	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

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