ABBV-CLS-628 for Polycystic Kidney Disease
(ANCHOR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, ABBV-CLS-628, to determine its safety and effectiveness in treating Autosomal Dominant Polycystic Kidney Disease (ADPKD), a genetic condition characterized by cysts in the kidneys. Participants will be divided into four groups, each receiving a different treatment, including a placebo (a non-active substance). The trial involves an intravenous dose every four weeks for 92 weeks, with regular hospital or clinic visits for check-ups. Individuals diagnosed with certain types of ADPKD and not currently undergoing treatment may be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in ADPKD treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop your current medications. However, if you are using non-approved treatments for ADPKD, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ABBV-CLS-628 is safe and well-tolerated in healthy individuals based on earlier studies. This experimental drug is currently being tested for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a genetic condition that causes kidney cysts. Previous research indicated the drug did not cause major side effects in healthy individuals. This finding is promising for its safety, but further testing is necessary in people with ADPKD to confirm these results.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about ABBV-CLS-628 because it offers a fresh approach to treating Polycystic Kidney Disease (PKD). Unlike current treatments, which mainly focus on managing symptoms and slowing disease progression, ABBV-CLS-628 targets the underlying mechanisms of cyst formation directly. This treatment works by potentially interfering with cyst growth pathways, which could effectively reduce or stabilize cysts over time. The administration of ABBV-CLS-628 every four weeks is designed to maintain consistent therapeutic levels, potentially offering more stable results compared to existing therapies. If successful, ABBV-CLS-628 could represent a significant advancement in PKD treatment by addressing the root cause rather than just the symptoms.
What evidence suggests that this trial's treatments could be effective for ADPKD?
Research shows that the drug ABBV-CLS-628, which participants in this trial may receive, might help treat Autosomal Dominant Polycystic Kidney Disease (ADPKD). Early findings suggest that this drug works by lowering the activity of a protein called IGF, believed to aid in kidney cyst growth. By targeting this protein, ABBV-CLS-628 could slow down or reduce cyst formation. The FDA has recognized the potential of this treatment by granting it Fast Track status, indicating promise in treating the condition. Although complete results are still needed, these early findings offer hope for people with ADPKD.15678
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
Adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who have a certain level of kidney function can join this study. They must fall into specific ADPKD classes based on Mayo Clinic's classification.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-CLS-628
Trial Overview
The trial is testing ABBV-CLS-628, a new drug for ADPKD. Participants are randomly assigned to one of four groups, receiving either the drug or placebo intravenously every 4 weeks for about 2 years, followed by a short observation period.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Calico Life Sciences LLC
Industry Sponsor
Citations
NCT06902558 | A Study to Assess Adverse Events and ...
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 ...
A Study to Assess Adverse Events and Effectiveness of ...
The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants.
3568 Safety and tolerability of ABBV-CLS-628: Results from a ...
By decreasing the bioavailability of IGF, ABBV-CLS-628 may provide an effective therapy for ADPKD. Here we present results from a first-in-human ...
FDA Fast Tracks Therapy for Inherited Kidney Disease - MPR
The FDA has granted Fast Track designation to ABBV-CLS-628 for the treatment of autosomal dominant polycystic kidney disease.
5.
clinicaltrials.eu
clinicaltrials.eu/trial/study-of-abbv-cls-628-to-evaluate-safety-and-effectiveness-in-adults-with-autosomal-dominant-polycystic-kidney-disease/Study of ABBV-CLS-628 to evaluate safety and ...
This medication is currently being tested to determine if it can safely and effectively help patients who have this inherited kidney condition.
A Study to Assess Adverse Events and Effectiveness of ...
The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants.
7.
renalandurologynews.com
renalandurologynews.com/news/fda-fast-tracks-therapy-for-inherited-kidney-disease/FDA Fast Tracks Therapy for Inherited Kidney Disease
In a phase 1 trial, the anti-PAPP-A monoclonal antibody was shown to be safe and well tolerated in healthy participants. ABBV-CLS-628 is ...
ABBV-CLS-628 - MedPath
Calico's ABBV-CLS-628 Receives FDA Fast Track Designation for Autosomal Dominant Polycystic Kidney Disease · Help Us Improve · MedPath.
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