Brief Description:
The M25-147 study is 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). 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 (of which approximately 5 sites in Australia). 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. The primary outcome measure is the cumulative rate of change from Baseline in Total Kidney Volume (TKV). Key Inclusion criteria include: • Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD. • Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m^2 and <90 mL/min/1.73 m^2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening. Key Exclusion Criteria include: • Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications. • Any exclusionary medical diseases, disorders, or conditions as described in the protocol.
Type of research:
Clinical Trial
Your time commitment:
Monthly
Consumers re-imbursed?
Expenses covered
Participants may be reimbursed for any reasonable travel, parking, meals and other expenses that they actually incur to attend the research project visits.
Who are researchers looking for?
Person with ADPKD
Contact for more info:
Website: NA
