ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Conditions

• Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• ABBV-CLS-628 — DRUG
  IntraVenous Infusion
• Placebo — DRUG
  IntraVenous Infusion

Study Details

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.

Key Dates

First listed

Mar 30, 2025

Start date

Jun 9, 2025

Status verified

Aug 2026

Primary completion

Aug 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) [ Time Frame: Week 96 ]

Central Contacts

• Calico Clinical Trial Communication
  650-754-6200
  [email protected]

Locations (39)

Find similar trials in Birmingham, AL

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