The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care.
Monica Cortinovis, Norberto Perico, Giuseppe Remuzzi
https://pubmed.ncbi.nlm.nih.gov/41348481Actively Recruiting
Phase 2
Age: 18Years - 65Years
All Genders
ID06582875
Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism
Led by University of Colorado, Denver · Updated on 2025-05-06
126
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
W
Washington University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a glucagon-like peptide 1 receptor agonist (GLP-1RA), a medication approved for weight management that also improves glucose and insulin response, on slowing kidney growth in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. This phase II, randomized, placebo-controlled, double-blind clinical trial aims to determine if one year of treatment can slow kidney growth, as well as assess changes in abdominal fat and kidney metabolism using advanced imaging techniques. The study also collects blood and urine samples to explore biological changes linked to treatment benefits while monitoring safety and tolerability. Participants will receive either tirzepatide, a GLP-1RA drug, or a placebo. The dosing starts at 2.5 mg once weekly and escalates to 5 mg once weekly after 4 weeks, maintaining the target dose for 10 months. Dose adjustments are allowed to manage side effects, with a minimum tolerated dose of 2.5 mg per week required to continue. Both study groups follow the same dose-escalation regimen, and all dose changes are recorded. During the 12-month study, participants undergo assessments at baseline, 6 months, and 12 months including magnetic resonance imaging to measure kidney volume and abdominal fat, blood tests for inflammation and metabolism markers, and urine tests. Researchers monitor kidney growth as the primary outcome and track secondary measures such as body weight, insulin resistance, and kidney oxygen consumption. Safety and tolerability are carefully followed throughout the study period, with total participation lasting one year.
CONDITIONS
Brief Title
Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosis of autosomal dominant polycystic kidney disease (ADPKD) based on modified Pei-Ravine criteria
- Body-mass index of 27 kg/m² or higher
- Estimated glomerular filtration rate of 30 mL/min/1.73m² or greater
- Mayo Classification of C, D, or E from a kidney ultrasound or MRI within the last 12 months
- Not currently participating in or planning to join any formal weight loss or physical activity programs or other interventional studies
- Ability to provide informed consent
You will not qualify if you...
- Diagnosis of diabetes mellitus
- Current use of or plans to start tolvaptan
- Hospitalization or major surgery within the last 3 months
- Uncontrolled high blood pressure (systolic >160 or diastolic >100 mm Hg)
- Pregnancy, breastfeeding, or unwillingness to use adequate birth control
- Regular use of medications that affect weight, appetite, food intake, or energy metabolism
- History of eating disorders such as anorexia nervosa, bulimia, or binge eating disorder
- Weight change greater than 5% in the past 3 months except postpartum weight loss
- Inability to cooperate with or contraindications for MRI including severe claustrophobia, implants, or non-removable piercings
- Personal or family history of medullary thyroid carcinoma, thyroid nodules, or multiple endocrine neoplasia type 2
- History of pancreatitis
- Weight over 450 pounds
- History or presence of malignant cancer within 5 years prior to screening visit
- Unwillingness or inability to comply with study procedures and assessments
- Severe claustrophobia or contraindications to MRI scanning
- Use of medications affecting metabolism or weight outside the study protocol
- Recent significant weight fluctuations unrelated to pregnancy or postpartum period
- Unstable or uncontrolled hypertension above study limits
- Recent hospitalization or surgery impacting study participation
- Pregnancy or lactation or lack of effective contraception use during the study period
- Eating disorder history affecting study participation
- Excessive body weight exceeding study limits
- Personal or family cancer history that may interfere with study safety or results
- Pancreatitis history affecting eligibility
- Contraindications for imaging procedures required by the study
- Use of medications that could interfere with study outcomes or safety
- Any other condition that may compromise study adherence or safety (not explicitly listed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive weekly subcutaneous injections of tirzepatide or placebo with a dose-escalation regimen over 12 months to evaluate effects on kidney growth and metabolic health.
Regular visits with dose adjustments as needed during the first 2 months, followed by monthly visits for the remaining 10 months
Trial Site Locations
Total: 1 location
1
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
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Research Team
K
Kristen Nowak, PhD, MPH
D
Diana George
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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