ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Purpose
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.
Condition
- Autosomal Dominant Polycystic Kidney Disease
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ABBV-CLS-628 Dose A |
Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks. |
|
|
Experimental ABBV-CLS-628 Dose B |
Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks. |
|
|
Experimental ABBV-CLS-628 Dose C |
Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks. |
|
|
Placebo Comparator Placebo |
Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Valiance Clinical Research - Huntington Park
Huntington Park, California 90255
Huntington Park, California 90255
Academic Medical Research Institute (AMRI) - Los Angeles
Los Angeles, California 90022
Los Angeles, California 90022
UC Irvine Medical Center
Orange, California 92868-3201
Orange, California 92868-3201
National Institute of Clinical Research - Pomona
Pomona, California 91768
Pomona, California 91768
University Of California, San Francisco
San Francisco, California 94143-2202
San Francisco, California 94143-2202
Yale University School of Medicine
New Haven, Connecticut 06510
New Haven, Connecticut 06510
South Florida Research Institute
Fort Lauderdale, Florida 33313
Fort Lauderdale, Florida 33313
Nature Coast Clinical Research - Inverness
Inverness, Florida 34452-4717
Inverness, Florida 34452-4717
Mayo Clinic Hospital Jacksonville
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Panax Clinical Research
Miami, Florida 33014
Miami, Florida 33014
University of Miami Don Suffer Clinical Research Building
Miami, Florida 33136
Miami, Florida 33136
Emory University School Of Medicine - Atlanta
Atlanta, Georgia 30322
Atlanta, Georgia 30322
CARE-Boise Kidney
Boise, Idaho 83706
Boise, Idaho 83706
CARE Institute - Idaho Falls
Idaho Falls, Idaho 83404
Idaho Falls, Idaho 83404
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611-2927
Chicago, Illinois 60611-2927
University of Iowa
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Tufts Medical Center
Boston, Massachusetts 02111-1552
Boston, Massachusetts 02111-1552
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University Of Michigan
Ann Arbor, Michigan 48109-5000
Ann Arbor, Michigan 48109-5000
St. Clair Nephrology
Shelby, Michigan 48315
Shelby, Michigan 48315
Mayo Clinic Hospital - Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Washington University School of Medicine - St Louis
St Louis, Missouri 63110
St Louis, Missouri 63110
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
Contact:
Icahn School of Medicine Mount Sinai
212-241-2339
Icahn School of Medicine Mount Sinai
212-241-2339
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599-0001
Chapel Hill, North Carolina 27599-0001
Brookview Hills Research Associates
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Northeast Clinical Research Center
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Nephrology Associates - Chattanooga - East Third Street
Chattanooga, Tennessee 37404
Chattanooga, Tennessee 37404
Knoxville Kidney Center
Knoxville, Tennessee 37923
Knoxville, Tennessee 37923
Renal Disease Research Institute
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Swedish Medical Center - Seattle
Seattle, Washington 98104
Seattle, Washington 98104
More Details
- Status
- Recruiting
- Sponsor
- Calico Life Sciences LLC
Study Contact
Calico Clinical Trial Communication650-754-6200
clinicaltrialcommunication@calicolabs.com