Filter Results
Clinical Studies
Results filtered:Study status:
Open
Closed for Enrollment
Open
-
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Evaluate The Safety And Efficacy Of ABBV-CLS-628 In Adult Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Rochester, Minn.,
Jacksonville, Fla.
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants.
ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide.
Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
-
A Study to Determine the Prevalence and Clinical Characteristics Associated With PKD1 Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to estimate the prevalence of PKD1 gene variant groups in the ADPKD population and describe the demographic and clinical characteristics of ADPKD by PKD1 gene variant group.
-
Exploratory analysis to identify biomarkers associated with Autosomal Dominant Polycystic Kidney Disease
Jacksonville, Fla.
The purpose of this study is to collect biological samples (whole blood and saliva) to develop and validate a genotype assay for Autosomal Dominant Polycystic Kidney Disease (ADPKD). Also, to determine the associations between genotype and ADPKD severity and/or progression, and to collect biological samples (blood and urine) to develop exploratory biomarker assays for potential correlation with ADPKD disease severity and/or progression.
-
Urinary urate levels in patients with ADPKD
Jacksonville, Fla.
The purpose of this study is to assess the levels of urate in urine samples of patients with autosomal dominant polycystic kidney disease (ADPKD). Investigate how different urinary urate levels are associated with the severity of the disease and patients’ demographics, comorbidities, and treatments.
Closed for Enrollment
-
A Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine Output and Increasing the Urine Osmolality in Patients with Hereditary Nephrogenic Diabetes Insipidus, Patients with Autosomal Dominant Polycystic Kidney Disease Treated with Tolvaptan, And Severely Polyuric Patients with Previous Lithium Administration (SerendipityPB1)
Jacksonville, Fla.
The objectives of this study are to evaluate the effectiveness and safety of PB in the treatment of patients with hereditary nephrogenic diabetes insipidus, to evaluate the effectiveness and safety of PB in polyuric patients with autosomal dominant polycystic kidney disease treated with tolvaptan, and to evaluate the effectiveness and safety of PB in polyuric patients previously treated with lithium.
-
A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose and an Open-Label Fixed-Dose Study in Patients with Autosomal Dominant Polycystic Kidney Disease to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of
RGLS8429
Rochester, Minn.,
Jacksonville, Fla.
The purpose of ths study is to assess the safety and tolerability of RGLS8429. Addiitionally, to assess the impact of RGLS8429 on ADPKD biomarkers
Other objectives are o assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) and to characterize the pharmacokinetic (PK) properties of RGLS8429 -To assess the impact of RGLS8429 on renal function.
.