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Influence of Simple Renal Cysts on Renal Function

Primary Purpose

Simple Renal Cyst, Renal Function Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CT scan with contrast
Nephroscintigraphy
Sponsored by
Moscow State University of Medicine and Dentistry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Simple Renal Cyst focused on measuring Simple Renal Cyst, Renal Function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients with simple kidney cyst Bosniak 1-2
  • Normal blood creatinine values

Exclusion Criteria:

  • Impossibility of performing CT with intravenous contrast enhancement.
  • Bosniak 3-4
  • CKD
  • Bilateral cysts
  • Multiple renal cysts
  • Sinus cysts
  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    kidneys with simple cysts

    contralateral kidneys without cyst

    Arm Description

    Patients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.

    Рatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    October 19, 2021
    Last Updated
    November 15, 2021
    Sponsor
    Moscow State University of Medicine and Dentistry
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05134077
    Brief Title
    Influence of Simple Renal Cysts on Renal Function
    Official Title
    Influence of Simple Renal Cysts on Renal Function: Cohort Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 16, 2022 (Anticipated)
    Primary Completion Date
    March 8, 2022 (Anticipated)
    Study Completion Date
    May 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Moscow State University of Medicine and Dentistry

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Simple Renal Cyst, Renal Function Disorder
    Keywords
    Simple Renal Cyst, Renal Function

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    kidneys with simple cysts
    Arm Type
    Experimental
    Arm Description
    Patients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.
    Arm Title
    contralateral kidneys without cyst
    Arm Type
    Active Comparator
    Arm Description
    Рatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.
    Intervention Type
    Procedure
    Intervention Name(s)
    CT scan with contrast
    Intervention Description
    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).
    Intervention Type
    Radiation
    Intervention Name(s)
    Nephroscintigraphy
    Intervention Description
    Nephroscintigraphy is necessary to determine the renal function
    Primary Outcome Measure Information:
    Title
    Renal function
    Description
    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
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Ratio of cyst size and volume of atrophic renal parenchyma
    Description
    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
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients with simple kidney cyst Bosniak 1-2 Normal blood creatinine values Exclusion Criteria: Impossibility of performing CT with intravenous contrast enhancement. Bosniak 3-4 CKD Bilateral cysts Multiple renal cysts Sinus cysts 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vigen Malkhasyan
    Phone
    +7(909) 644-16-88
    Email
    vigenmalkhasyan@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sergey Sukhikh
    Phone
    +7(985) 307-74-50
    Email
    docsukhikh@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tukhtasin Mahmudov
    Organizational Affiliation
    Moscow state university of medicine and dentistry named after A.I. Evdokimov
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Influence of Simple Renal Cysts on Renal Function

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