Autosomal Dominant Polycystic KidneyPhase 2NCT06582875
Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
A Phase 2 study testing Tirzepatide in people with Autosomal Dominant Polycystic Kidney and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to glucose and insulin, can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney, Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
Kristen Nowak, PhD, MPH, 303-724-4842, Kristen.Nowak@cuanschutz.edu
Kristen Nowak, PhD, MPH
About this study
Official title: Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism
The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to glucose and insulin, can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat and kidney metabolism using cutting-edge images techniques. Blood and urine samples will provide further insight into biological changes that may be linked to the benefits of the intervention, while ensuring careful monitoring of safety and tolerability.
Read the detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is a common inherited disorder that leads to kidney failure. The only approved treatment to decelerate kidney disease progression in patients with ADPKD is tolvaptan, but its usage is limited due to frequent side effects affecting adherence. Thus, alternative interventions that may slow ADPKD progression hold considerable clinical importance. In line with the general population, body-mass index and insulin resistance have been increasing in patients with ADPKD. The investigators have shown that visceral adiposity associates strongly with accelerated progression of early-stage ADPKD. Pilot study suggested that diet-induced weight loss may slow kidney growth (% in height-adjusted total kidney volume [htTKV] by magnetic resonance imaging), and the study team is currently evaluating the efficacy of daily caloric restriction-induced weight loss for slowing ADPKD progression in a phase IIa clinical trial. However, the long-term adherence to lifestyle interventions is challenging, making pharmacological interventions a compelling adjunct or alternative. Moreover, the study team recently demonstrated that adults with ADPKD and preserved kidney function exhibited insulin resistance (via the gold-standard hyperinsulinemic-euglycemic clamps) and impaired kidney oxidative metabolism (via 11C-acetate PET), which were strongly associated with htTKV. These novel data suggest that targeting improvements in insulin sensitivity and kidney oxidative metabolism, in addition to weight loss, may slow ADPKD progression. Glucagon-like peptide 1 receptor agonists (GLP-1RAs) were recently FDA-approved for the treatment of obesity and show promise in substantially reducing adiposity and improving insulin sensitivity. Additionally, evidence indicates that GLP-1RAs may transform CKD management by reducing kidney events in patients with and without diabetes, via effects extending beyond glycemic modulation, and in part via attenuated kidney inflammation and oxidative stress. However, GLP-1RAs have not yet been evaluated as a novel therapy for slowing ADPKD progression in patients with overweight/obesity. Thus, the current study is a 12-month, phase II, randomized, placebo-controlled, double-blind clinical trial using a GLP-1RA in 126 adults with ADPKD and overweight or obesity to slow kidney growth (primary outcome). The trial will also evaluate changes in total body weight, adipose volume and function, insulin resistance, kidney oxidative metabolism, and inflammation, and carefully monitor safety and tolerability. As a novel therapeutic in ADPKD, GLP-1RAs could transform the treatment landscape for patients.
- Conditions
- Autosomal Dominant Polycystic Kidney, Obesity
- Being tested
- Tirzepatide, Placebo
- Keywords
- GLP1RA
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Zepbound
Titrated to dose of 5 mg once weekly subcutaneous
PlaceboOther
Titrated to dose of 5 mg once weekly subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | To minimize the risk of gastrointestinal adverse events, we will use a standard dose-escalation regimen for tirzepatide (placebo-matched), starting at 2.5 mg once weekly (OW) at randomization. After 4 weeks of treatment at 2.5 mg, the dose will be escalated to 5 mg OW, which will be maintained for another 4 weeks and then continued as the target dose for 10 months until the end of treatment. As with other nutrient stimulating hormone (NuSH) therapies, dose reductions and extensions of dose-escalation intervals will be permitted if participants experience unacceptable adverse events. The minimum tolerated dose required for continued study participation is 2.5 mg/week. All dose changes will be documented in the study records. Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | To minimize the risk of gastrointestinal adverse events, we will use a standard dose-escalation regimen for tirzepatide (placebo-matched), starting at 2.5 mg once weekly (OW) at randomization. After 4 weeks of treatment at 2.5 mg, the dose will be escalated to 5 mg OW, which will be maintained for another 4 weeks and then continued as the target dose for 10 months until the end of treatment. As with other nutrient stimulating hormone (NuSH) therapies, dose reductions and extensions of dose-escalation intervals will be permitted if participants experience unacceptable adverse events. The minimum tolerated dose required for continued study participation is 2.5 mg/week. All dose changes will be documented in the study records. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in height-Adjusted Total kidney volume
To assess kidney growth,height-adjusted total kidney volume will be measured by magnetic resonance imaging at baseline and 12 months to determine annual percent change.
Measured: Baseline, 12-months
Secondary outcomes (15)
Change in body weight
Change in body weight over the 12-month period will be measured using a calibrated digital scale.
Measured: Baseline, 12-months
Change in abdominal adiposity
Abdominal adiposity (subcutaneous, visceral, and total) will be assessed by magnetic resonance imaging.
Measured: Baseline, 12-months
Change in adiponectin (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 6-months, 12-months
Change in leptin (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 6-months, 12-months
Change in interleukin-6 (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 6-months, 12-months
Change in tumor necrosis-factor-alpha (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 6-months, 12-months
Change in high-sensitivity C-reactive protein (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 6-months, 12-months
Change in 8-isoprostane (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 6-months, 12-months
Change in copeptin (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 6-months, 12-months
Change in HOMA-IR
The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will use fasting glucose and insulin to calcuate insulin sensitivity
Measured: Baseline, 6-months, 12-months
Change in HOMA-β
The Homeostatic Model Assessment of β-cell function (HOMA-β) will use fasting glucose and insulin to calcuate insulin secretion.
Measured: Baseline, 6-months, 12-months
Change in 8-isoprostane (urinary)
Sport urine samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 6-months, 12-months
Change in copeptin (urinary)
Sport urine samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 6-months, 12-months
Change in renal oxygen consumption
Renal oxygen consumption will be assessed by a PET/CT scan using 11-C acetate in a sub-set of participants
Measured: Baseline, 12-months
Change in gut microbiota
16S rRNA gene sequencing will be used for taxonomic characterization of the gut microbiota in a subset of participants.
Measured: Baseline, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start6 Mar 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic KidneyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582875
- Sponsor's protocol ID
- 24-0594
- Other IDs
- R01DK138915-01A1
- Status last verified
- May 2025
- First submitted
- 26 Aug 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Nowak KL, Chonchol M. Cardiovascular-Kidney-Metabolic Syndrome in Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2026 Sep 25. doi: 10.1681/ASN.0000001291. Online ahead of print. No abstract available.
PubMed 42789922Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12.
PubMed 41385299Cortinovis M, Perico N, Remuzzi G. The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care. Clin J Am Soc Nephrol. 2025 Dec 5. doi: 10.2215/CJN.0000000975. Online ahead of print.
PubMed 41348481
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism
- ClinicalTrials.gov ID
- NCT06582875
- Acronym / sponsor ID
- 24-0594
- Conditions
- Autosomal Dominant Polycystic Kidney, Obesity
- Keywords
- GLP1RA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to glucose and insulin, can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat and kidney metabolism using cutting-edge images techniques. Blood and urine samples will provide further insight into biological changes that may be linked to the benefits of the intervention, while ensuring careful monitoring of safety and tolerability.
Detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is a common inherited disorder that leads to kidney failure. The only approved treatment to decelerate kidney disease progression in patients with ADPKD is tolvaptan, but its usage is limited due to frequent side effects affecting adherence. Thus, alternative interventions that may slow ADPKD progression hold considerable clinical importance. In line with the general population, body-mass index and insulin resistance have been increasing in patients with ADPKD. The investigators have shown that visceral adiposity associates strongly with accelerated progression of early-stage ADPKD. Pilot study suggested that diet-induced weight loss may slow kidney growth (% in height-adjusted total kidney volume [htTKV] by magnetic resonance imaging), and the study team is currently evaluating the efficacy of daily caloric restriction-induced weight loss for slowing ADPKD progression in a phase IIa clinical trial. However, the long-term adherence to lifestyle interventions is challenging, making pharmacological interventions a compelling adjunct or alternative. Moreover, the study team recently demonstrated that adults with ADPKD and preserved kidney function exhibited insulin resistance (via the gold-standard hyperinsulinemic-euglycemic clamps) and impaired kidney oxidative metabolism (via 11C-acetate PET), which were strongly associated with htTKV. These novel data suggest that targeting improvements in insulin sensitivity and kidney oxidative metabolism, in addition to weight loss, may slow ADPKD progression. Glucagon-like peptide 1 receptor agonists (GLP-1RAs) were recently FDA-approved for the treatment of obesity and show promise in substantially reducing adiposity and improving insulin sensitivity. Additionally, evidence indicates that GLP-1RAs may transform CKD management by reducing kidney events in patients with and without diabetes, via effects extending beyond glycemic modulation, and in part via attenuated kidney inflammation and oxidative stress. However, GLP-1RAs have not yet been evaluated as a novel therapy for slowing ADPKD progression in patients with overweight/obesity. Thus, the current study is a 12-month, phase II, randomized, placebo-controlled, double-blind clinical trial using a GLP-1RA in 126 adults with ADPKD and overweight or obesity to slow kidney growth (primary outcome). The trial will also evaluate changes in total body weight, adipose volume and function, insulin resistance, kidney oxidative metabolism, and inflammation, and carefully monitor safety and tolerability. As a novel therapeutic in ADPKD, GLP-1RAs could transform the treatment landscape for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideTo minimize the risk of gastrointestinal adverse events, we will use a standard dose-escalation regimen for tirzepatide (placebo-matched), starting at 2.5 mg once weekly (OW) at randomization. After 4 weeks of treatment at 2.5 mg, the dose will be escalated to 5 mg OW, which will be maintained for another 4 weeks and then continued as the target dose for 10 months until the end of treatment. As with other nutrient stimulating hormone (NuSH) therapies, dose reductions and extensions of dose-escalation intervals will be permitted if participants experience unacceptable adverse events. The minimum tolerated dose required for continued study participation is 2.5 mg/week. All dose changes will be documented in the study records. |
| Placebo | Placebo comparator | Other: PlaceboTo minimize the risk of gastrointestinal adverse events, we will use a standard dose-escalation regimen for tirzepatide (placebo-matched), starting at 2.5 mg once weekly (OW) at randomization. After 4 weeks of treatment at 2.5 mg, the dose will be escalated to 5 mg OW, which will be maintained for another 4 weeks and then continued as the target dose for 10 months until the end of treatment. As with other nutrient stimulating hormone (NuSH) therapies, dose reductions and extensions of dose-escalation intervals will be permitted if participants experience unacceptable adverse events. The minimum tolerated dose required for continued study participation is 2.5 mg/week. All dose changes will be documented in the study records. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: ZepboundTitrated to dose of 5 mg once weekly subcutaneous | Drug | Tirzepatide |
| PlaceboTitrated to dose of 5 mg once weekly subcutaneous | Other | Placebo |
Primary outcome
Change in height-Adjusted Total kidney volume
Time frame: Baseline, 12-months
To assess kidney growth,height-adjusted total kidney volume will be measured by magnetic resonance imaging at baseline and 12 months to determine annual percent change.
15 secondary outcomes
Change in body weight
Time frame: Baseline, 12-months
Change in abdominal adiposity
Time frame: Baseline, 12-months
Change in adiponectin (circulating)
Time frame: Baseline, 6-months, 12-months
Change in leptin (circulating)
Time frame: Baseline, 6-months, 12-months
Change in interleukin-6 (circulating)
Time frame: Baseline, 6-months, 12-months
Change in tumor necrosis-factor-alpha (circulating)
Time frame: Baseline, 6-months, 12-months
Change in high-sensitivity C-reactive protein (circulating)
Time frame: Baseline, 6-months, 12-months
Change in 8-isoprostane (circulating)
Time frame: Baseline, 6-months, 12-months
Change in copeptin (circulating)
Time frame: Baseline, 6-months, 12-months
Change in HOMA-IR
Time frame: Baseline, 6-months, 12-months
Change in HOMA-β
Time frame: Baseline, 6-months, 12-months
Change in 8-isoprostane (urinary)
Time frame: Baseline, 6-months, 12-months
Change in copeptin (urinary)
Time frame: Baseline, 6-months, 12-months
Change in renal oxygen consumption
Time frame: Baseline, 12-months
Change in gut microbiota
Time frame: Baseline, 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Derived from this study: PubMed 42789922Nowak KL, Chonchol M. Cardiovascular-Kidney-Metabolic Syndrome in Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2026 Sep 25. doi: 10.1681/ASN.0000001291. Online ahead of print. No abstract available.
- Derived from this study: PubMed 41385299Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12.
- Derived from this study: PubMed 41348481Cortinovis M, Perico N, Remuzzi G. The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care. Clin J Am Soc Nephrol. 2025 Dec 5. doi: 10.2215/CJN.0000000975. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Autosomal Dominant Polycystic Kidney and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Nowak, PhD, MPH (3037244842, Kristen.Nowak@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in height-Adjusted Total kidney volume (time frame: Baseline, 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06582875, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.