Adult Polycystic Kidney DiseaseNCT03442647
Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function
A study testing sinistrin clearance dynamic measurement in people with Adult Polycystic Kidney Disease and Kidney Neoplasms, run by Thomas Mueller at 1 site in Switzerland.
Trial summary
The number of people with kidney disease is constantly rising and renal failure represents one of the major health care burdens globally. An accurate measurement of kidney function is urgently needed to better understand and treat loss of renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Polycystic Kidney Disease, Kidney Neoplasms, Kidney Dysfunction
- What is being tested?
- sinistrin clearance dynamic measurement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2018to 30 Aug 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential living kidney donor
- Patients with diagnosed ADPKD
- Patients with primary kidney tumor requiring nephrectomy
- Female and male patients over 18 years of age
Who cannot join
- Bilateral kidney tumor
- Kidney metastases of a tumor of other origin
- Renal failure that requires dialysis
- Pregnant patient
- Incomplete medical records
- Patients with diabetes mellitus
- Patients who cannot tolerate iv fluids
- Hypersensitivity to the active substance (sinistrin) or to any of the excipients
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Thomas F Mueller, Prof., +41 44 255 33 84, thomas.mueller@usz.ch
Andreja Figurek, Dr. med., +41 44 255 33 84, andreja.figurek@usz.ch
About this study
The number of people with kidney disease is constantly rising and renal failure represents one of the major health care burdens globally. An accurate measurement of kidney function is urgently needed to better understand and treat loss of renal function. Kidneys have an intrinsic reserve capacity to respond to a higher work load by increasing filtration in their nephrons. The number of nephrons and their reserve capacity define how well kidneys can adapt to an increased demand and disease.
The degree of renal reserve capacity becomes particularly important when the number of functioning nephrons is significantly reduced either due to surgical removal of one kidney as in living kidney donation or in tumor nephrectomy or due to progressive injury as in autosomal dominant polycystic kidney disease (ADPKD). A reduced functional reserve likely reflects an impaired adaptive capacity and increased risk of accelerated loss of function in the remaining single kidney or in kidneys exposed to a disease. Despite the importance of accurately measuring baseline and reserve capacity renal function, due to the time- and laborintensive procedure, in clinical routine this testing is rarely done.
Read more
Investigators aim to measure renal functional reserve (RFR) and loss of function in patients undergoing nephrectomy (living kidney donors and renal tumor patients) as well as in patients with ADPKD.
The results should provide evidence whether renal functional reserve indeed predicts adaptive capacity and functional loss after removal of a healthy kidney (living donors), of a tumor kidney (cancer patients) or in progressive kidney disorders (ADPKD patients).
Investigators are confident that the proposed project will enhance the understanding of progressive kidney disease and with this improve donor safety, planning of tumor nephrectomy, and prediction of renal functional loss as well as provide a strong argument that dynamic renal function testing, i.e. accurate measurement of baseline and reserve capacity, is necessary in certain disease entities.
Read the detailed description
The measurement of RFR will be performed by dynamic testing of the changes in baseline glomerular filtration rate (GFR) induced by an oral protein load. Sinistrin (a polyfructosan with identical clearance characteristics to inulin) will be used to measure GFR.
- Being tested
- sinistrin clearance dynamic measurement
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinistrin clearance dynamic measurementDiagnostic test
sinistrin clearance measurements will be performed before and 90 min after oral protein load
| Study group | Role | What they receive |
|---|---|---|
| Living donors | Active comparator | sinistrin clearance dynamic measurement Receives: Diagnostic Test: sinistrin clearance dynamic measurement |
| ADPKD patients | Active comparator | sinistrin clearance dynamic measurement Receives: Diagnostic Test: sinistrin clearance dynamic measurement |
| Patients with primary renal tumor | Active comparator | sinistrin clearance dynamic measurement Receives: Diagnostic Test: sinistrin clearance dynamic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFR predicts renal functional decline
Sinistrin levels in plasma before and after oral protein load. Participants with impaired RFR are expected to have higher sinitrin levels in plasma.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jun 2018 (estimated)
- Primary completion30 Aug 2018 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Mueller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Mueller, University of Zurich
- Investigators
- Thomas F Mueller, Prof., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442647
- Sponsor's protocol ID
- 2017-01839
- Other IDs
- 2017
- Status last verified
- May 2018
- First submitted
- 5 Feb 2018
- Last updated
- 14 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function
- ClinicalTrials.gov ID
- NCT03442647
- Acronym / sponsor ID
- 2017-01839
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thomas MuellerUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 30 Aug 2018 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 22 Feb 2018 (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 number of people with kidney disease is constantly rising and renal failure represents one of the major health care burdens globally. An accurate measurement of kidney function is urgently needed to better understand and treat loss of renal function. Kidneys have an intrinsic reserve capacity to respond to a higher work load by increasing filtration in their nephrons. The number of nephrons and their reserve capacity define how well kidneys can adapt to an increased demand and disease.
The degree of renal reserve capacity becomes particularly important when the number of functioning nephrons is significantly reduced either due to surgical removal of one kidney as in living kidney donation or in tumor nephrectomy or due to progressive injury as in autosomal dominant polycystic kidney disease (ADPKD). A reduced functional reserve likely reflects an impaired adaptive capacity and increased risk of accelerated loss of function in the remaining single kidney or in kidneys exposed to a disease. Despite the importance of accurately measuring baseline and reserve capacity renal function, due to the time- and laborintensive procedure, in clinical routine this testing is rarely done.
Investigators aim to measure renal functional reserve (RFR) and loss of function in patients undergoing nephrectomy (living kidney donors and renal tumor patients) as well as in patients with ADPKD.
The results should provide evidence whether renal functional reserve indeed predicts adaptive capacity and functional loss after removal of a healthy kidney (living donors), of a tumor kidney (cancer patients) or in progressive kidney disorders (ADPKD patients).
Investigators are confident that the proposed project will enhance the understanding of progressive kidney disease and with this improve donor safety, planning of tumor nephrectomy, and prediction of renal functional loss as well as provide a strong argument that dynamic renal function testing, i.e. accurate measurement of baseline and reserve capacity, is necessary in certain disease entities.
Detailed description
The measurement of RFR will be performed by dynamic testing of the changes in baseline glomerular filtration rate (GFR) induced by an oral protein load. Sinistrin (a polyfructosan with identical clearance characteristics to inulin) will be used to measure GFR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Living donors | Active comparator | Diagnostic Test: sinistrin clearance dynamic measurementsinistrin clearance dynamic measurement |
| ADPKD patients | Active comparator | Diagnostic Test: sinistrin clearance dynamic measurementsinistrin clearance dynamic measurement |
| Patients with primary renal tumor | Active comparator | Diagnostic Test: sinistrin clearance dynamic measurementsinistrin clearance dynamic measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Potential living kidney donor
- Patients with diagnosed ADPKD
- Patients with primary kidney tumor requiring nephrectomy
- Female and male patients over 18 years of age
Key exclusion criteria (8 listed)
- Bilateral kidney tumor
- Kidney metastases of a tumor of other origin
- Renal failure that requires dialysis
- Pregnant patient
- Incomplete medical records
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 |
|---|---|---|
| sinistrin clearance dynamic measurementsinistrin clearance measurements will be performed before and 90 min after oral protein load | Diagnostic test | ADPKD patients, Living donors, Patients with primary renal tumor |
Primary outcome
RFR predicts renal functional decline
Time frame: up to 8 months
Sinistrin levels in plasma before and after oral protein load. Participants with impaired RFR are expected to have higher sinitrin levels in plasma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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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.
Thomas F Mueller, Prof. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sinistrin clearance dynamic measurement in people with Adult Polycystic Kidney Disease and Kidney Neoplasms, run by Thomas Mueller at 1 site in Switzerland.
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 8 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: status not confirmed, as of the sponsor's last update on 14 May 2018. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas F Mueller, Prof. (+41 44 255 33 84, thomas.mueller@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFR predicts renal functional decline (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2018.