Using a medication to slow kidney growth in patients with a genetic kidney disease

Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism

This study is testing if a new medication can help slow down kidney growth in overweight or obese adults with a genetic kidney disease called ADPKD.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT06582875 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a glucagon-like peptide-1 receptor agonist, tirzepatide, in slowing kidney growth in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. Participants will receive either the medication or a placebo for one year, with assessments of kidney size, abdominal fat, and metabolic changes through advanced imaging techniques and biological sample analysis. The study aims to provide an alternative to current treatments, which have limited adherence due to side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of ADPKD, a body mass index of 27 kg/m² or higher, and preserved kidney function.

Not a fit: Patients with diabetes mellitus or those currently using tolvaptan will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for slowing the progression of kidney disease in patients with ADPKD, potentially improving their quality of life.

How similar studies have performed: While this approach is novel in the context of ADPKD, previous studies have shown that weight management can positively impact kidney health, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* 18-65 years of age
* ADPKD diagnosis based on the modified Pei-Ravine criteria
* Body-mass index of ≥27 kg/m\^2
* Estimated glomerular filtration rate ≥ 30 mL/min/1.73m\^2
* Mayo Classification of C, D, or E, calculated from a previous kidney ultrasound or MRI performed within the last 12 months
* Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study
* Ability to provide informed consent

Exclusion Criteria:

* Diabetes mellitus
* Tolvaptan usage or plans to initiate tolvaptan
* History of hospitalization or major surgery within the last 3 months
* Uncontrolled hypertension (systolic blood pressure \> 160 or diastolic blood pressure \>100 mm Hg)
* Pregnancy, lactation, or unwillingness to use adequate birth control
* Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism
* History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder
* Weight change of \>5% in the past 3 months for any reason except post-partum weight loss
* Inability to cooperate with or clinical contraindication for MRI including: severe claustrophobia, implants, devices, or non-removable body piercings
* Presence or personal history of malignant neoplasm within 5 years prior to the day of screening
* Personal or family history of medullary thyroid carcinoma, thyroid nodule, or multiple endocrine neoplasia type 2
* Prior history of pancreatitis
* Weight ≥450 lb

Where this trial is running

Aurora, Colorado

• University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)

Study contacts

• Study coordinator: Kristen Nowak, PhD, MPH

Conditions Autosomal Dominant Polycystic Kidney; Obesity; GLP1RA