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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517143-31-00 | Other Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-CLS-628 Dose A | Experimental | Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks. |
|
| ABBV-CLS-628 Dose B | Experimental | Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks. |
|
| ABBV-CLS-628 Dose C | Experimental | Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-CLS-628 | Drug | IntraVenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) | TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD). | Week 96 |
| Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to approximately 118 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline | eGFR will be measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021). | Week 96 |
| Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Calico Clinical Trial Communication | Contact | 650-754-6200 | clinicaltrialcommunication@calicolabs.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Calico Life Sciences LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Clinical Research - Garden Grove /ID# 271418 | Recruiting | Garden Grove | California | 92844 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41348481 | Derived | Cortinovis M, Perico N, Remuzzi G. The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care. Clin J Am Soc Nephrol. 2025 Dec 5. doi: 10.2215/CJN.0000000975. Online ahead of print. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Placebo | Drug | IntraVenous Infusion |
|
TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD). |
| Week 48 |
| Absolute Change in eGFR From Baseline | eGFR will be measured using the CKD-EPI Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021). | Week 48 |
| Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR | Defined as initiation of renal replacement therapy (RRT) or kidney transplantation, or a confirmed decline in eGFR of 40% or more from baseline, sustained for at least 4 weeks. | Up to Week 96 |
| Valiance Clinical Research - Huntington Park /ID# 270634 | Recruiting | Huntington Park | California | 90255 | United States |
| Academic Medical Research Institute - Los Angeles /ID# 270502 | Recruiting | Los Angeles | California | 90022 | United States |
| UC Irvine Medical Center /ID# 270811 | Recruiting | Orange | California | 92868-3201 | United States |
| University Of California, San Francisco /ID# 270326 | Recruiting | San Francisco | California | 94143-2202 | United States |
| Yale University School of Medicine /ID# 270675 | Recruiting | New Haven | Connecticut | 06510 | United States |
| Horizon Research Group - Coral Gables /ID# 270857 | Recruiting | Coral Gables | Florida | 33134 | United States |
| South Florida Research Institute /ID# 270848 | Recruiting | Fort Lauderdale | Florida | 33313 | United States |
| Nature Coast Clinical Research - Inverness /ID# 270875 | Recruiting | Inverness | Florida | 34452-4717 | United States |
| Mayo Clinic Hospital Jacksonville /ID# 271011 | Recruiting | Jacksonville | Florida | 32224 | United States |
| Panax Clinical Research /ID# 270851 | Recruiting | Miami | Florida | 33014 | United States |
| Infigo Clinical Research /ID# 270844 | Recruiting | Sanford | Florida | 32771 | United States |
| Emory University School Of Medicine - Atlanta /ID# 271947 | Recruiting | Atlanta | Georgia | 30322 | United States |
| CARE-Boise Kidney /ID# 270628 | Recruiting | Boise | Idaho | 83706 | United States |
| CARE Institute - Idaho Falls /ID# 272005 | Recruiting | Idaho Falls | Idaho | 83404 | United States |
| Northwestern University Feinberg School of Medicine /ID# 271409 | Recruiting | Chicago | Illinois | 60611-2927 | United States |
| University of Iowa /ID# 270492 | Recruiting | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center /ID# 271946 | Recruiting | Kansas City | Kansas | 66160 | United States |
| Tufts Medical Center /ID# 270323 | Recruiting | Boston | Massachusetts | 02111-1552 | United States |
| Beth Israel Deaconess Medical Center /ID# 271408 | Recruiting | Boston | Massachusetts | 02215 | United States |
| University Of Michigan /ID# 270436 | Recruiting | Ann Arbor | Michigan | 48109-5000 | United States |
| St. Clair Nephrology /ID# 271445 | Recruiting | Shelby | Michigan | 48315 | United States |
| Mayo Clinic Hospital Rochester /ID# 270428 | Recruiting | Rochester | Minnesota | 55905 | United States |
| Washington University /ID# 271436 | Recruiting | St Louis | Missouri | 63110 | United States |
| Icahn School of Medicine at Mount Sinai /ID# 271440 | Recruiting | New York | New York | 10029 | United States |
| University of North Carolina at Chapel Hill /ID# 274800 | Recruiting | Chapel Hill | North Carolina | 27599-0001 | United States |
| Brookview Hills Research Associates /ID# 271449 | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Northeast Clinical Research Center /ID# 270838 | Recruiting | Bethlehem | Pennsylvania | 18017 | United States |
| University of Pennsylvania /ID# 270301 | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Nephrology Associates - Chattanooga - East Third Street /ID# 270701 | Recruiting | Chattanooga | Tennessee | 37404 | United States |
| Knoxville Kidney Center /ID# 270706 | Recruiting | Knoxville | Tennessee | 37923 | United States |
| Arlington Nephrology /ID# 270494 | Recruiting | Arlington | Texas | 76015 | United States |
| Renal Disease Research Institute /ID# 270339 | Recruiting | Fort Worth | Texas | 76104 | United States |
| University of Virginia /ID# 270329 | Recruiting | Charlottesville | Virginia | 22908 | United States |
| Swedish Medical Center - Seattle /ID# 270344 | Recruiting | Seattle | Washington | 98104 | United States |
| Westmead Hospital /ID# 271156 | Recruiting | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women's Hospital /ID# 271224 | Recruiting | Brisbane | Queensland | 4029 | Australia |
| Royal Adelaide Hospital /ID# 273114 | Recruiting | Adelaide | South Australia | 5000 | Australia |
| Fiona Stanley Hospital /ID# 271173 | Recruiting | Murdoch | Western Australia | 6150 | Australia |
| Cliniques Universitaires UCL Saint-Luc /ID# 270635 | Recruiting | Brussels | Brussels Capital | 1200 | Belgium |
| UZ Leuven /ID# 270638 | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
| CHU de Liege /ID# 270631 | Recruiting | Liège | 4000 | Belgium |
| Hopital Edouard Herriot /ID# 271142 | Recruiting | Lyon | Auvergne-Rhône-Alpes | 69003 | France |
| CHU Brest - Hôpital de la Cavale Blanche /ID# 271114 | Recruiting | Brest | Brittany Region | 29200 | France |
| CHU Toulouse - Hôpital Rangueil /ID# 271138 | Recruiting | Toulouse | Occitanie | 31400 | France |
| Hopital de la Conception /ID# 271152 | Recruiting | Marseille | Provence-Alpes-Côte d'Azur Region | 13005 | France |
| Hopital Universitaire Necker Enfants Malades /ID# 271146 | Recruiting | Paris | Île-de-France Region | 75015 | France |
| TUM Klinikum rechts der Isar /ID# 271522 | Recruiting | Munich | Bavaria | 81675 | Germany |
| Medizinische Hochschule Hannover /ID# 270938 | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
| Universitaetsklinikum Koeln /ID# 270937 | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935 | Recruiting | Berlin | 10117 | Germany |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563 | Recruiting | Rome | Roma | 00161 | Italy |
| Hokkaido University Hospital /ID# 271385 | Recruiting | Sapporo | Hokkaido | 060-8648 | Japan |
| National Hospital Organization Kyoto Medical Center /ID# 271782 | Recruiting | Kyoto | Kyoto | 612-8555 | Japan |
| Juntendo University Hospital /ID# 271722 | Recruiting | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 272022 | Recruiting | Chiba | 260-8712 | Japan |
| Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247 | Recruiting | Dordrecht | South Holland | 3318 AT | Netherlands |
| Lumc /Id# 271844 | Recruiting | Leiden | South Holland | 2333 ZA | Netherlands |
| Universitair Medisch Centrum Groningen /ID# 271249 | Recruiting | Groningen | 9713 GR | Netherlands |
| Unidade Local de Saude de Almada-Seixal, EPE /ID# 271257 | Recruiting | Almada | Setúbal District | 2805-267 | Portugal |
| 2CA-Braga, Hospital de Braga /ID# 271258 | Recruiting | Braga | 4710-243 | Portugal |
| Unidade Local de Saude do Algarve, EPE /ID# 271819 | Recruiting | Faro | 8000-386 | Portugal |
| Unidade Local de Saude de Sao Jose, EPE /ID# 271255 | Recruiting | Lisbon | 1150-199 | Portugal |
| Unidade Local de Saude de Lisboa Ocidental, EPE /ID# 271261 | Recruiting | Lisbon | 1449-005 | Portugal |
| Pusan National University Hospital /ID# 271429 | Recruiting | Busan | Busan Gwang Yeogsi | 49241 | South Korea |
| Keimyung University Dongsan Hospital /ID# 272455 | Recruiting | Daegu | Gyeongsangbuk-do | 42601 | South Korea |
| Seoul National University Hospital /ID# 271331 | Recruiting | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| SMG-SNU Boramae Medical Center /ID# 271227 | Recruiting | Seoul | Seoul Teugbyeolsi | 07061 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital /ID# 271329 | Recruiting | Seoul | Seoul Teugbyeolsi | 07441 | South Korea |
| Hospital Universitari de Bellvitge /ID# 270489 | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Fundacio Puigvert /ID# 270491 | Recruiting | Barcelona | 08025 | Spain |
| Hospital Universitario Virgen de las Nieves /ID# 270918 | Recruiting | Granada | 18014 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 270485 | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre /ID# 270829 | Recruiting | Madrid | 28041 | Spain |
| Hospital Clínico Universitario de Valencia /ID# 270837 | Recruiting | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
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