What is Autosomal Dominant Polycystic Kidney Disease?
Autosomal dominant polycystic kidney disease, also called ADPKD, is the most common form of inherited kidney disease worldwide. It is characterized by the development and growth of cysts in both kidneys. As cysts enlarge, kidneys can increase in size and function may decline over decades.1 In more than 50% of people, ADPKD progresses to kidney failure by age 60, at which point dialysis or kidney transplant are required.2
ADPKD can be painful and can significantly affect quality of life.3 Common symptoms and complications include:
· Belly, side, or back pain
· High blood pressure
· Kidney stones
· Urinary tract or kidney infections
· Blood in the urine
Currently, there is no cure for ADPKD. Once a diagnosis is made, care focuses on managing symptoms, reducing complications, and preserving kidney function as long as possible.
Calico is currently recruiting people for an ongoing Phase 2 study evaluating an investigational therapy for treating ADPKD. For more information, please visit our clinical trial website at www.anchoradpkd.com.
Investigating a potential ADPKD pathway: PAPP-A and IGF signaling
Calico and our partners have been investigating the connection between ADPKD and Pregnancy Associated Plasma Protein A, or PAPP-A. PAPP-A was first discovered in pregnant women, but it exists in people of all ages and sexes. PAPP-A influences Insulin-like Growth Factor (IGF) signaling, which plays an important role in development and disease biology.
In ADPKD, elevated PAPP-A activity in the cystic kidney may increase IGF signaling, potentially contributing to cyst development and growth. The goal of Calico’s clinical study is to understand whether modulating IGF signaling through reducing PAPP-A activity can help slow the development and growth of cysts in the kidneys.
Now enrolling: Phase 2 clinical trial
Calico, in collaboration with AbbVie, is evaluating ABBV-CLS-628, an investigational human monoclonal antibody that inhibits PAPP-A, in a Phase 2 clinical trial (NCT06902558). By modulating IGF signaling, ABBV-CLS-628 aims to slow disease progression in people diagnosed with ADPKD.
Calico is currently recruiting people for this ongoing Phase 2 study. For more information please visit our clinical trial website at www.anchoradpkd.com.
ABBV-CLS-628 has been granted U.S. FDA Fast Track Designation and Orphan Drug Designation for the treatment of ADPKD. It was studied in a Phase 1 study in healthy volunteers in which it was shown to be safe and well tolerated with no significant adverse events reported to be associated with the drug.
ABBV-CLS-628 is currently used only under clinical investigation and is not approved for use in any markets at this time. The most up-to-date information about this investigational study can be found by visiting www.clinicaltrials.gov and entering “NCT06902558” in the “Other terms” field. For information in Europe, visit euclinicaltrials.eu, click “Search clinical trials” and enter “2024-517143-31-00” in the “Contain all of these terms” field.
About our clinical trials
Calico and our collaborative partners are committed to designing and conducting clinical studies with the highest integrity and ethical standards and we are devoted to the safety and well-being of the people who participate. All interventional clinical trials sponsored by Calico are designed in accordance with, and authorized by, the appropriate regulatory agencies. If you have additional questions, please contact us at: clinicaltrialcommunication@calicolabs.com.
References
1 – NIH NIDDK
2 – National Kidney Foundation
3 – PKD Foundation