Influence of Simple Renal Cysts on Renal Function

November 15, 2021 updated by: Moscow State University of Medicine and Dentistry

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

  1. The symmetry of the function of both kidneys is analyzed
  2. The relationship between the presence of a simple kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
  3. The relationship between the maximum size of a kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
  4. The relationship between the volume of the atrophied kidney parenchyma and a decrease in its function as compared with a healthy kidney is analyzed.
  5. Correspondence of GFR indices obtained by scintigraphy and by calculation using the Schwartz formula

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kidneys with simple cysts
Patients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.
Procedure: CT scan with contrast
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).
Radiation: Nephroscintigraphy
Nephroscintigraphy is necessary to determine the renal function
Active Comparator: contralateral kidneys without cyst
Рatients involve from Citi Clinical Hospital with simple renal accidentally discovered cyst.
Procedure: CT scan with contrast
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).
Radiation: Nephroscintigraphy
Nephroscintigraphy is necessary to determine the renal function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of cyst size and volume of atrophic renal parenchyma
Time Frame: 1 month
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow State University of Medicine and Dentistry

Investigators

  • Principal Investigator: Tukhtasin Mahmudov, Moscow State University of Medicine and Dentistry named after A.I. Evdokimov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 16, 2022

Primary Completion (Anticipated)

March 8, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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