Polycystic Kidney Disease, AdultPENGUINNCT04407481
PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN)
An observational study of Polycystic Kidney Disease, Adult and Polycystic Kidney, Autosomal Dominant, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Polycystic Kidney Disease, Adult, Polycystic Kidney, Autosomal Dominant
- What is being tested?
- Aminohippurate Sodium Inj 20%, Iohexol Inj 300 milligrams per milliliter (MG/ML) and PET/CT Scan
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 13 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Patients with Autosomal dominant polycystic kidney disease
- Age 18-40 years
- BMI >= 18.5 and <30 kg/m2
- Weight <350 lbs
Who cannot join
- Diabetes mellitus, based on previous diagnosis
- Albuminuria (≥30mg/g) or estimated glomerular filtration rate (eGFR) <75ml/min/1.73m2
- Pregnancy or nursing
- Anemia
- Allergy to shellfish or iodine
- Vaptan therapy (e.g. tolvaptan)
- Uncontrolled hypertension (average ≥140/90 mmHg)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: PENGUIN: PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD
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.
- Being tested
- Aminohippurate Sodium Inj 20%, Iohexol Inj 300 milligrams per milliliter (MG/ML), PET/CT Scan
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminohippurate Sodium Inj 20%Drug
Also called •- Sodium 4-amino hippurate (PAH) inj 20% 2g/10 milliliter (mL) • Para-aminohippurate • Aminohippuric acid
Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
Iohexol Inj 300 milligrams per milliliter (MG/ML)Drug
Also called omnipaque 300
Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
PET/CT ScanRadiation
Imaging used to visualize the kidneys and quantify renal metabolic activity
| Study group | Role | What they receive |
|---|---|---|
| Adults with autosomal dominant polycystic kidney disease | All participants will undergo DXA scan, PET/CT using 11-C acetate to measure renal oxygen consumption, hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity, and renal clearance testing using iohexol and para-aminohippurate (PAH) to quantify glomerular filtration rate (GFR) and effective renal plasma flow (ERPF). Receives: Drug: Aminohippurate Sodium Inj 20%; Drug: Iohexol Inj 300 milligrams per milliliter (MG/ML); Radiation: PET/CT Scan | |
| Healthy Controls | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal oxygen consumption
11-C Acetate PET/CT
Measured: 30 minutes
Insulin Sensitivity
Hyperinsulinemic-Euglycemic Clamp
Measured: 4.5 hours
Secondary outcomes (15)
Mitochondrial Function
Blood draw for mitochondrial DNA copy number
Measured: 5 minutes
Mitochondrial Function
Blood draw for untargeted metabolite assessment of the tricyclic acid (TCA) cycle
Measured: 5 minutes
Mitochondrial Function
Blood draw for targeted assessment and quantification of glucose oxidation using an established metabolite panel
Measured: 5 minutes
Mitochondrial Function
Blood draw for untargeted metabolite assessment of Free Fatty Acid (FFA) oxidation
Measured: 5 minutes
Glomerular Filtration Rate (GFR)
Iohexol Clearance Study
Measured: 3 hours
Effective Renal Plasma Flow (ERPF)
PAH Clearance Study
Measured: 2.5 hours
Renin-Angiotensin-Aldosterone-System Activity
Blood draw for Plasma Renin levels
Measured: 5 minutes
Renin-Angiotensin-Aldosterone-System Activity
Blood draw for Angiotensin II levels
Measured: 5 minutes
Renin-Angiotensin-Aldosterone-System Activity
Blood draw for Copeptin levels
Measured: 5 minutes
Kidney Injury Biomarkers
Chitinase-3-like protein 1 (YKL-40) levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for Neutrophil gelatinase-associated lipocalin (NGAL) levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for Kidney Injury Molecule 1 (KIM-1) levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for Interleukin-18 (IL-18) levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for Tumor Necrosis Factor Receptor 1/2 (TNF-R 1/2) levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for monocyte chemoattractant protein-1 (MCP-1) levels
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Nov 2020
- Primary completion13 Oct 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Kidney Disease, AdultStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407481
- Sponsor's protocol ID
- 20-0277
- Acronym
- PENGUIN
- Status last verified
- Feb 2023
- First submitted
- 19 May 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bjornstad P, Richard G, Choi YJ, Nowak KL, Steele C, Chonchol MB, Nadeau KJ, Vigers T, Pyle L, Tommerdahl K, van Raalte DH, Hilkin A, Driscoll L, Birznieks C, Hopp K, Wang W, Edelstein C, Nelson RG, Gregory AV, Kline TL, Blondin D, Gitomer B. Kidney Energetics and Cyst Burden in Autosomal Dominant Polycystic Kidney Disease: A Pilot Study. Am J Kidney Dis. 2024 Sep;84(3):286-297.e1. doi: 10.1053/j.ajkd.2024.02.016. Epub 2024 Apr 15.
PubMed 38621633
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PENGUIN: PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD
- ClinicalTrials.gov ID
- NCT04407481
- Acronym / sponsor ID
- PENGUIN / 20-0277
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 29 May 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with autosomal dominant polycystic kidney disease | – | Drug: Aminohippurate Sodium Inj 20%, Drug: Iohexol Inj 300 milligrams per milliliter (MG/ML), Radiation: PET/CT ScanAll participants will undergo DXA scan, PET/CT using 11-C acetate to measure renal oxygen consumption, hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity, and renal clearance testing using iohexol and para-aminohippurate (PAH) to quantify glomerular filtration rate (GFR) and effective renal plasma flow (ERPF). |
| Healthy Controls | – | –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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Patients with Autosomal dominant polycystic kidney disease
- Age 18-40 years
- BMI >= 18.5 and <30 kg/m2
- Weight <350 lbs
Key exclusion criteria (7 listed)
- Diabetes mellitus, based on previous diagnosis
- Albuminuria (≥30mg/g) or estimated glomerular filtration rate (eGFR) <75ml/min/1.73m2
- Pregnancy or nursing
- Anemia
- Allergy to shellfish or iodine
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 |
|---|---|---|
| Aminohippurate Sodium Inj 20%Also: •- Sodium 4-amino hippurate (PAH) inj 20% 2g/10 milliliter (mL) • Para-aminohippurate • Aminohippuric acidDiagnostic aid/agent used to measure effective renal plasma flow (ERPF) | Drug | Adults with autosomal dominant polycystic kidney disease |
| Iohexol Inj 300 milligrams per milliliter (MG/ML)Also: omnipaque 300Diagnostic aid/agent used to measure glomerular filtration rate (GFR) | Drug | Adults with autosomal dominant polycystic kidney disease |
| PET/CT ScanImaging used to visualize the kidneys and quantify renal metabolic activity | Radiation | Adults with autosomal dominant polycystic kidney disease |
Primary outcome
Renal oxygen consumption
Time frame: 30 minutes
11-C Acetate PET/CT
Insulin Sensitivity
Time frame: 4.5 hours
Hyperinsulinemic-Euglycemic Clamp
15 secondary outcomes
Mitochondrial Function
Time frame: 5 minutes
Mitochondrial Function
Time frame: 5 minutes
Mitochondrial Function
Time frame: 5 minutes
Mitochondrial Function
Time frame: 5 minutes
Glomerular Filtration Rate (GFR)
Time frame: 3 hours
Effective Renal Plasma Flow (ERPF)
Time frame: 2.5 hours
Renin-Angiotensin-Aldosterone-System Activity
Time frame: 5 minutes
Renin-Angiotensin-Aldosterone-System Activity
Time frame: 5 minutes
Renin-Angiotensin-Aldosterone-System Activity
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Derived from this study: PubMed 38621633Bjornstad P, Richard G, Choi YJ, Nowak KL, Steele C, Chonchol MB, Nadeau KJ, Vigers T, Pyle L, Tommerdahl K, van Raalte DH, Hilkin A, Driscoll L, Birznieks C, Hopp K, Wang W, Edelstein C, Nelson RG, Gregory AV, Kline TL, Blondin D, Gitomer B. Kidney Energetics and Cyst Burden in Autosomal Dominant Polycystic Kidney Disease: A Pilot Study. Am J Kidney Dis. 2024 Sep;84(3):286-297.e1. doi: 10.1053/j.ajkd.2024.02.016. Epub 2024 Apr 15.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Kidney Disease, Adult and Polycystic Kidney, Autosomal Dominant, 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 3 Feb 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal oxygen consumption (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 NCT04407481, which also lists 1 linked publication.
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 3 Feb 2023.