Chronic Kidney Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTcollection of serum/capillary creatinine values
collection of serum/capillary creatinine values
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | 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. | 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. |
Countries
Germany, Hungary, Spain, United States
Participant flow
Recruitment details
Multicentre, non-randomised, low-intervention study that did not involve administration of study drug, which aimed to investigate the estimated Glomerular Filtration Rate (eGRF) 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.
Pre-assignment details
Patients were screened for eligibility prior to participation in the trial. They underwent a screening period of up to 2 weeks from the time of informed consent. Patients who successfully completed the screening and met all inclusion criteria, including the availability of requisite historical eGFR data, and did not meet any of the exclusion criteria, qualified for enrolment into the 48 weeks prospective phase of the study.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Chronic Kidney Disease - Overall Population Patients with chronic kidney disease (CKD), including patients with non-diabetic chronic kidney disease (non-DKD) and diabetic chronic kidney disease (DKD). This study did not involve administration of study drug. | 210 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Exhausted all attempts to contact subject | 1 |
| Overall Study | Study cancelled by sponsor | 220 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Patients With Chronic Kidney Disease - Overall Population |
|---|---|
| Age, Continuous | 68.2 Years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 150 Participants |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 210 |
| other Total, other adverse events | 0 / 210 |
| serious Total, serious adverse events | 0 / 210 |
Outcome results
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.
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.
Population: Full Analysis Set (FAS): FAS includes all patients entered into the 48-week prospective phase of the study who have at least one post-baseline assessment. Summary statistics are reported by overall and DKD/non-DKD patient populations. The n's in each category for DKD/non-DKD may not add up to the overall number, since separate random slope models are used leading to differences in estimated eGFR slope in each of the calculations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | Retrospective Phase: > -1 | 9 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | Retrospective Phase: > -3 to -1 | 27 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | Retrospective Phase: <= -3 | 78 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -1 (in Retrospective Phase) to <= -3 (in Prospective Phase) | 4 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from <= -3 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase) | 11 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -1 (in Retrospective Phase) to > -1 (in Prospective Phase) | 4 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase) | 1 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -3 to -1 (in Retrospective Phase) to > -1 (in Prospective Phase) | 12 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -3 to -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase) | 6 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -3 to -1 (in Retrospective Phase) to <= -3 (in Prospective Phase) | 9 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from <= -3 (in Retrospective Phase) to > -1 (in Prospective Phase) | 45 Participants |
| Patients With Diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from <= -3 (in Retrospective Phase) to <= -3 (in Prospective Phase) | 22 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from <= -3 (in Retrospective Phase) to <= -3 (in Prospective Phase) | 52 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | Retrospective Phase: > -1 | 15 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -3 to -1 (in Retrospective Phase) to <= -3 (in Prospective Phase) | 11 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -1 (in Retrospective Phase) to > -1 (in Prospective Phase) | 8 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | Retrospective Phase: > -3 to -1 | 20 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from <= -3 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase) | 3 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -3 to -1 (in Retrospective Phase) to > -1 (in Prospective Phase) | 7 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase) | 1 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | Retrospective Phase: <= -3 | 61 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from <= -3 (in Retrospective Phase) to > -1 (in Prospective Phase) | 6 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -1 (in Retrospective Phase) to <= -3 (in Prospective Phase) | 6 Participants |
| Patients With Non-diabetic Chronic Kidney Disease - Patient Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -3 to -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase) | 2 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -3 to -1 (in Retrospective Phase) to > -1 (in Prospective Phase) | 18 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -3 to -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase) | 5 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from <= -3 (in Retrospective Phase) to > -1 (in Prospective Phase) | 39 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from <= -3 (in Retrospective Phase) to <= -3 (in Prospective Phase) | 66 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | Retrospective Phase: <= -3 | 146 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -1 (in Retrospective Phase) to > -1 (in Prospective Phase) | 9 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -3 to -1 (in Retrospective Phase) to <= -3 (in Prospective Phase) | 20 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -1 (in Retrospective Phase) to <= -3 (in Prospective Phase) | 10 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | Retrospective Phase: > -1 | 21 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from <= -3 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase) | 41 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | Retrospective Phase: > -3 to -1 | 43 Participants |
| Patients With Chronic Kidney Disease - Overall Population | Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values | from > -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase) | 2 Participants |