Autosomal Dominant Polycystic Kidney Disease
Conditions
Keywords
Autosomal Dominant Polycystic Kidney Disease (ADPKD), ABBV-CLS-628
Brief summary
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.
Interventions
DRUGABBV-CLS-628
IntraVenous Infusion
DRUGPlacebo
IntraVenous Infusion
Sponsors
Calico Life Sciences LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) | Week 96 | 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). |
| Number of Participants with Adverse Events (AEs) | Up to approximately 118 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline | Week 96 | eGFR will be measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021). |
| Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) | Week 48 | 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). |
| Absolute Change in eGFR From Baseline | Week 48 | eGFR will be measured using the CKD-EPI Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021). |
| Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR | Up to Week 96 | 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. |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Portugal, South Korea, Spain, United States
Contacts
CONTACTCalico Clinical Trial Communication
STUDY_DIRECTORStudy Director
Calico Life Sciences LLC
Outcome results
None listed