Chronic Kidney DiseasePhase 2NCT04881448

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

A Phase 2 study testing collection of serum/capillary creatinine values in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 25 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease
What is being tested?: collection of serum/capillary creatinine values
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 223 participants
Where: 25 sitesin 4 countries
Study dates: 16 Sep 2021to 15 Jul 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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]).

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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).
Further exclusion criteria apply.

Trial locations and contacts

25 sites in 4 countries.

Country

City, postcode or hospital

25 sites in 4 countries

United States19 sites

Davita Clinical Research-Hartford
Bloomfield, Connecticut, 06002
Tidewater Kidney Specialists
Chesapeake, Virginia, 23320
Columbus Regional Research Institute
Columbus, Georgia, 31904
DaVita Clinical Research
Edina, Minnesota, 55435-2129
Davita Clinical Research
El Paso, Texas, 79925
Sunbeam Clinical Research
Greenville, Texas, 75402-6004
DaVita Clinical Research
Houston, Texas, 77054
Nephrology Consultants, LLC
Huntsville, Alabama, 35805
DaVita Clinical Research
Las Vegas, Nevada, 89128
Med-Care Research
Miami, Florida, 33125
International Research Associates
Miami, Florida, 33183
Nephrology & Hypertension Assoc., PC
Middlebury, Connecticut, 06762-2843
DaVita Clinical Research
San Antonio, Texas, 78251
DaVita Clinical Research (DCR) Spartanburg
Spartanburg, South Carolina, 29306
Kidney Medical Associates, PLLC
The Bronx, New York, 10461
DaVita Clinical Research
The Woodlands, Texas, 77384
Desert Cities Dialysis - Amethyst
Victorville, California, 92392
Kidney & Hypertension Center
Victorville, California, 92395
DaVita Clinical Research
Wauwatosa, Wisconsin, 53226

Other trials in United States

Germany3 sites

DaVita Clinical Research Germany GmbH
Düsseldorf, 40210
InnoDiab Forschung GmbH
Essen, 45136
DaVita Clinical Research Germany GmbH
Geilenkirchen, 52511

Other trials in Germany

Hungary2 sites

DRC Drug Research Ltd
Balatonfüred, 8230
Szent Imre Korhaz, Budapest
Budapest, 1115

Other trials in Hungary

Spain1 site

Hospital Virgen Macarena
Seville, 41009

Other trials in Spain

About this study

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

Conditions: Chronic Kidney Disease
Being tested: collection of serum/capillary creatinine values
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

collection of serum/capillary creatinine valuesDiagnostic test
collection of serum/capillary creatinine values

Study groups in NCT04881448
Study group	Role	What they receive
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. Receives: Diagnostic Test: collection of serum/capillary creatinine values

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 202115 Jul 2022

First posted11 May 2021
Study start16 Sep 2021
Primary completion15 Jul 2022
Study completion15 Jul 2022

Why it stopped: Recruitment challenges

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04881448
Sponsor's protocol ID: 1366-0026
Status last verified: Jul 2023
First submitted: 4 May 2021
Last updated: 4 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Homogeneity Between eGFR Slopes Derived From Retrospective Clinical Practice Data and eGFR Slopes Derived From Prospectively Collected, Protocol-driven Data
ClinicalTrials.gov ID: NCT04881448
Acronym / sponsor ID: 1366-0026
Conditions: Chronic Kidney Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment challenges
Enrolment: 223 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 16 Sep 2021 (actual)
Primary completion: 15 Jul 2022 (actual)
Study completion: 15 Jul 2022 (actual)
First posted: 11 May 2021 (actual)
Results: Posted 4 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with chronic kidney disease - overall population	Experimental	Diagnostic Test: collection of serum/capillary creatinine valuesPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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).

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
collection of serum/capillary creatinine valuescollection of serum/capillary creatinine values	Diagnostic test	Patients with chronic kidney disease - overall population

Primary outcome

Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values
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.
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.

Results and safety

Results posted to the registry on 4 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Chronic Kidney Disease - Overall Population	223	0

Primary outcome: Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values

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.. Count of participants. Unit: Participants

Measure	Patients With Diabetic Chronic Kidney Disease - Patient Population n = 114	Patients With Non-diabetic Chronic Kidney Disease - Patient Population n = 96	Patients With Chronic Kidney Disease - Overall Population n = 210
Retrospective Phase: > -1	9	15	21
Retrospective Phase: > -3 to -1	27	20	43
Retrospective Phase: <= -3	78	61	146
from > -1 (in Retrospective Phase) to > -1 (in Prospective Phase)	4	8	9
from > -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase)	1	1	2
from > -1 (in Retrospective Phase) to <= -3 (in Prospective Phase)	4	6	10
from > -3 to -1 (in Retrospective Phase) to > -1 (in Prospective Phase)	12	7	18
from > -3 to -1 (in Retrospective Phase) to > -3 to -1 (in Prospective Phase)	6	2	5

Population analysed: 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.

Adverse events

Time frame: From signing the informed consent onwards until the end of study visit, up to 50 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Chronic Kidney Disease - Overall Population	0 of 210 (0%)	0 of 210 (0%)	0 of 210

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Related trials for Chronic Kidney Disease

Active, not recruitingPhase 2
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End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing collection of serum/capillary creatinine values in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 25 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Germany, Hungary, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Homogeneity (eGFR Slope Shift Table) Between eGFR Slopes Derived From Retrospective and Prospective eGFR Values (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04881448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.