NCT04578548Phase 2Terminated

A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study sponsor: Lakefront Biotherapeutics NV · LKFT

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-12-14Actual

Enrollment · participants66Actual

Source updated2024-08-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Autosomal Dominant Polycystic Kidney Disease

Treatments or interventions studied

GLPG2737Drug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: DB Period: Mean Percent Change From MRI Baseline in htTKV; description: htTKV is used in participants with ADPKD disease to predict the onset of renal insufficiency. htTKV was calculated using TKV (in mL) obtained from MRI divided by height (in m). MRI Baseline: For MRI assessments, all non-missing values before the first study drug administration in the study +14 days (included) was considered as the primary baseline definition. Results were derived by mean of the individual slopes (i.e. using all MRI performed between baseline and Week 52).; timeFrame: MRI Baseline up to Week 52; measure: DB Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs; description: An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug, whether or not considered related to it. A serious adverse event (SAE) is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results a congenital anomaly/birth defect or other medically important event. A TEAE was defined as an AE observed after starting administration of the study drug until 30 days after last DB dose or 1 day before OLE dose, whichever occurred first.; timeFrame: From first dose to Week 56

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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