Simple Renal CystNCT05134077
Influence of Simple Renal Cysts on Renal Function
A study testing CT scan with contrast and Nephroscintigraphy in people with Simple Renal Cyst and Renal Function Disorder, run by Moscow State University of Medicine and Dentistry.
Trial summary
This is a prospective, cohort, randomized clinical trial examining the effect of simple renal cysts on renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Simple Renal Cyst, Renal Function Disorder
- What is being tested?
- CT scan with contrast and Nephroscintigraphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2022to 1 May 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with simple kidney cyst Bosniak 1-2
- Normal blood creatinine values
Who cannot join
- Impossibility of performing CT with intravenous contrast enhancement.
- Bosniak 3-4
- CKD
- Bilateral cysts
- Multiple renal cysts
- Sinus cysts
Show all 29Show fewer
- Cysts with a max size less than 2 cm.
- Single kidney
- Chronic kidney disease and conditions associated with the potential decrease of kidney function
- Glomerulonephritis
- Chronic pyelonephritis
- Amyloidosis
- Diabetes
- Autoimmune diseases
- Urolithiasis
- Kidney and upper urinary tract surgery
- Anomalies of the kidneys and upper urinary tract with impaired outflow
- Calcification of the renal arteries
- Renal artery stenosis
- Hypertensive nephropathy
- Severe concomitant diseases requiring
- Chemotherapy
- Long-term (more than 10 days) antibiotic therapy in the last month
- Long-term (more than 7 days) use of NSAIDs in the last month
- Diagnostic and therapeutic manipulations accompanied by the introduction of X-ray contrast agents
- Secondarily shriveled or non-functioning kidney
- Kidney hypoplasia
- Accessory kidney
- a decrease in GFR below normal values for a kidney without a cyst (as determined by nephroscintigraphy)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Simple Renal Cysts on Renal Function: Cohort Clinical Trial.
This is a prospective, cohort, randomized clinical trial examining the effect of simple renal cysts on renal function.
Read the detailed description
This study is planned to include patients from S.I. Spasokukotskiy Citi Clinical Hospital with simple renal accidentally discovered cyst.
The aim of the study is to evaluate the impact of simple renal cysts on renal function and explore the correlation between cyst's size, parenchymal atrophy, and renal function.
After receiving the results, the analysis of the data obtained is carried out.
- The symmetry of the function of both kidneys is analyzed
- The relationship between the presence of a simple kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
- The relationship between the maximum size of a kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
- The relationship between the volume of the atrophied kidney parenchyma and a decrease in its function as compared with a healthy kidney is analyzed.
- Correspondence of GFR indices obtained by scintigraphy and by calculation using the Schwartz formula
- Conditions
- Simple Renal Cyst, Renal Function Disorder
- Being tested
- CT scan with contrast, Nephroscintigraphy
- Keywords
- Simple Renal Cyst, Renal Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan with contrastProcedure or surgery
CT scan with contrast is necessary to determine the position of renal cysts, their location, and size (determine volume of atrophic parenchyma will be calculated).
NephroscintigraphyRadiation
Nephroscintigraphy is necessary to determine the renal function
| Study group | Role | What they receive |
|---|---|---|
| kidneys with simple cysts | Experimental | Patients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst. Receives: Procedure: CT scan with contrast; Radiation: Nephroscintigraphy |
| contralateral kidneys without cyst | Active comparator | Рatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst. Receives: Procedure: CT scan with contrast; Radiation: Nephroscintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Glomerular filtration rate (GFR, ml/min/1.73 m2) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the glomeruli each minute. A GFR of 60 or higher is in the normal range. A GFR below 60 may mean kidney disease. A GFR of 15 or lower may mean kidney failure.
The measurement of the glomerular filtration rate will be measured according to the results of the blood test and the results of nephroscintigraphy
Measured: 1 month
Secondary outcomes (1)
Ratio of cyst size and volume of atrophic renal parenchyma
Computed tomography with contrast will be used to determine the position of renal cysts, their location, size and volume of atrophic parenchyma (cm2) are calculated
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start16 Feb 2022 (estimated)
- Primary completion8 Mar 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simple Renal CystStudies 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
- Parallel groups
- Model description
- We present a cohort study of patients with renal cysts (the first group - kidneys with cysts, the second group - kidneys without cysts in the studied patients). All patients will undergo contrast-enhanced CT of the urinary system (volume of atrophic parenchyma will be calculated), as well as nephroscintigraphy.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow State University of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tukhtasin Mahmudov, Principal investigator, Moscow state university of medicine and dentistry named after A.I. Evdokimov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134077
- Sponsor's protocol ID
- SRC
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Simple Renal Cysts on Renal Function: Cohort Clinical Trial.
- ClinicalTrials.gov ID
- NCT05134077
- Acronym / sponsor ID
- SRC
- Conditions
- Simple Renal Cyst, Renal Function Disorder
- Keywords
- Simple Renal Cyst, Renal Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Moscow State University of Medicine and DentistryUniversity, hospital or other
- Study start
- 16 Feb 2022 (estimated)
- Primary completion
- 8 Mar 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 24 Nov 2021 (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.
This is a prospective, cohort, randomized clinical trial examining the effect of simple renal cysts on renal function.
Detailed description
This study is planned to include patients from S.I. Spasokukotskiy Citi Clinical Hospital with simple renal accidentally discovered cyst.
The aim of the study is to evaluate the impact of simple renal cysts on renal function and explore the correlation between cyst's size, parenchymal atrophy, and renal function.
After receiving the results, the analysis of the data obtained is carried out.
- The symmetry of the function of both kidneys is analyzed
- The relationship between the presence of a simple kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
- The relationship between the maximum size of a kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
- The relationship between the volume of the atrophied kidney parenchyma and a decrease in its function as compared with a healthy kidney is analyzed.
- Correspondence of GFR indices obtained by scintigraphy and by calculation using the Schwartz formula
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We present a cohort study of patients with renal cysts (the first group - kidneys with cysts, the second group - kidneys without cysts in the studied patients). All patients will undergo contrast-enhanced CT of the urinary system (volume of atrophic parenchyma will be calculated), as well as nephroscintigraphy.
| Arm | Type | Receives |
|---|---|---|
| kidneys with simple cysts | Experimental | Procedure: CT scan with contrast, Radiation: NephroscintigraphyPatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst. |
| contralateral kidneys without cyst | Active comparator | Procedure: CT scan with contrast, Radiation: NephroscintigraphyРatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with simple kidney cyst Bosniak 1-2
- Normal blood creatinine values
Key exclusion criteria (29 listed)
- Impossibility of performing CT with intravenous contrast enhancement.
- Bosniak 3-4
- CKD
- Bilateral cysts
- Multiple renal cysts
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 |
|---|---|---|
| CT scan with contrastCT scan with contrast is necessary to determine the position of renal cysts, their location, and size (determine volume of atrophic parenchyma will be calculated). | Procedure or surgery | contralateral kidneys without cyst, kidneys with simple cysts |
| NephroscintigraphyNephroscintigraphy is necessary to determine the renal function | Radiation | contralateral kidneys without cyst, kidneys with simple cysts |
Primary outcome
Renal function
Time frame: 1 month
Glomerular filtration rate (GFR, ml/min/1.73 m2) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the glomeruli each minute. A GFR of 60 or higher is in the normal range. A GFR below 60 may mean kidney disease. A GFR of 15 or lower may mean kidney failure. The measurement of the glomerular filtration rate will be measured according to the results of the blood test and the results of nephroscintigraphy
1 secondary outcome
Ratio of cyst size and volume of atrophic renal parenchyma
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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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.
Tukhtasin Mahmudov principal investigator
Moscow state university of medicine and dentistry named after A.I. Evdokimov
Questions about this trial
What is this clinical trial studying?
A study testing CT scan with contrast and Nephroscintigraphy in people with Simple Renal Cyst and Renal Function Disorder, run by Moscow State University of Medicine and Dentistry.
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 2 inclusion and 29 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Vigen Malkhasyan (+7(909) 644-16-88, vigenmalkhasyan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: 1 month). 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 24 Nov 2021.