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NCT04407481 · ClinicalTrials.gov registry record
PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN)
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 22
- Enrollment target
NCT04407481: Completed study, sponsored by University of Colorado, Denver.
NCT04407481 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04407481 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 22 participants
- Enrollment target
Study Summary
Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic cause of end-stage kidney disease (ESKD). The disorder is characterized by development and continued growth of multiple cysts requiring renal replacement therapy in 50% of patients by age 60 years. However, ADPKD is also a complex metabolic disorder defined by insulin resistance (IR) and mitochondrial dysfunction which may be causally related to cyst expansion, kidney function decline and contribute to reduced life expectancy. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is proposed as a novel unifying early pathway in the development and expansion of renal cysts in ADPKD. By examining the interplay between renal O2 consumption and energy utilization in young adults with and without ADPKD, the investigators hope to identify novel therapeutic targets to impede development of cyst expansion in future trials. The investigators propose to address the specific aims in a cross-sectional study with 20 adults with ADPKD (50% female, ages 18-40 years). Comparative data will be provided from healthy adults from an ongoing study with similar study design and methods (CROCODILE Study: Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance). For this protocol, participants will complete a one day study visit at Children's Hospital Colorado. Patients will undergo a dual energy x-ray absorptiometry (DXA) to assess body composition, and a 11C-acetate positron emission tomography (PET/CT) scan to quantify renal O2 consumption. After the PET/CT, participants will undergo a hyperinsulinemic-euglycemic clamp while fasting to quantify insulin sensitivity. Glomerular Filtration Rate (GFR) and Effective Renal Plasma Flow (ERPF) will be measured by iohexol and PAH clearances during the hyperinsulinemic-euglycemic clamp.
Primary Outcome
11-C Acetate PET/CT
Interventions
- DRUG Aminohippurate Sodium Inj 20%
- DRUG Iohexol Inj 300 milligrams per milliliter (MG/ML)
- RADIATION PET/CT Scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-11-01 |
| Est. Completion | 2022-10-13 |
What the finished NCT04407481 record still lists
NCT04407481 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Aminohippurate Sodium Inj 20% is the first listed.
NCT04407481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04407481 about?
NCT04407481 is a clinical study titled "PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN)". Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic cause of end-stage kidney disease (ESKD). The disorder is characterized by development and continued growth of multiple cysts requiring renal replacement therapy in 50% of patients by age 60 years. However, ADPKD is al...
What is the current status of trial NCT04407481?
This trial is currently completed. The enrollment target is 22 participants. The study started on 2020-11-01. Estimated completion is 2022-10-13.
What interventions are being tested in trial NCT04407481?
The interventions under investigation include: Aminohippurate Sodium Inj 20% (DRUG), Iohexol Inj 300 milligrams per milliliter (MG/ML) (DRUG), PET/CT Scan (RADIATION).
Who is sponsoring clinical trial NCT04407481?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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