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A Study of ABBV-CLS-628 in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease
EU CTIS ID: 2024-517143-31-00
What this study is testing
To assess the safety and efficacy of ABBV-CLS-628 in trial participants with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Trial participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any washout, screening or study-specific procedures.
- Age 18 (or higher age limit defined per regional definitions) to 55 years of age, both inclusive at the time of consent.
- Diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
- ADPKD Classe 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD.
- eGFR >= 30 mL/min/1.73 m2 and < 90 mL/min/1.73 m2 , using the CKD-EPI equation at Screening.
- Negative serum pregnancy test at Screening and negative urine pregnancy test at baseline.
You likely can't join if
- Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.
- Positive result on the urine drug screen at Screening unless explained by concomitant medication use.
- Concurrent participation in any other interventional trial.
- Any exclusionary medical diseases, disorders, or conditions.
- Hypertension not controlled by antihypertensive therapy (per investigator's judgment) at screening and baseline.
- History of Renal Replacement Therapy.
See the full eligibility criteria
- Trial participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any washout, screening or study-specific procedures.
- Age 18 (or higher age limit defined per regional definitions) to 55 years of age, both inclusive at the time of consent.
- Diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
- ADPKD Classe 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD.
- eGFR >= 30 mL/min/1.73 m2 and < 90 mL/min/1.73 m2 , using the CKD-EPI equation at Screening.
- Negative serum pregnancy test at Screening and negative urine pregnancy test at baseline.
- Female trial participants of childbearing potential enrolled must agree to use two forms of protocol-specified, contraception, one of which is highly effective from Study Day 1.
- Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.
- Positive result on the urine drug screen at Screening unless explained by concomitant medication use.
- Concurrent participation in any other interventional trial.
- Any exclusionary medical diseases, disorders, or conditions.
- Hypertension not controlled by antihypertensive therapy (per investigator's judgment) at screening and baseline.
- History of Renal Replacement Therapy.
- Anticipated need for dialysis or transplantation within the next year.
- Any active infections including but not limited to the following: Positive for HIV, HBV, HCV.
- Immunocompromised per investigator's judgment.
- History of clinically significant (per investigator's discretion) drug or alcohol abuse within the last 6 months prior to Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Korea, Republic of
- Japan
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Korea, Republic of; Japan; Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.