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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04439747
Other study ID # 20180438
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2020

Study information

Verified date June 2020
Source Belarusian State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Methods of diagnostic and treatment of hormonal disorders in patients with chronic kidney disease (CKD) will be developed and implemented in real clinical practice. As a result of the project, new scientific data will be obtained on the relationship of hyperprolactinemia and impaired functioning of the pituitary-gonadal axis, changes in functioning of the renin-angiotensin-aldosterone system will be revealed, and the characteristics of the thyroid and parathyroid status in patients with CKD will be determined, including receiving renal replacement therapy (RRT) and after kidney transplantation, which will improve the efficiency of diagnosis and treatment of hormonal disorders in the early stages of the disease, reduce the direct financial costs of the diagnostic and treatment process primarily due to the optimization of hormonal studies and treatment of the revealed disorders, as well as will prevent the progression of CKD and the severity of the condition of this category of patients due to the development of hormonal dysfunctions.


Description:

1. Assessment of prevalence, clinical manifestations and pathological significance in a cohort of patients with CKD:

- hyperprolactinemia, hormonal disorders of a pituitary -gonad axis ;

- disorders of renin-angiotensin-aldosterone system;

- pathology of the thyroid and parathyroid glands.

2. Analysis of CKD impact on the development of structural changes in the thyroid gland and parathyroid glands according to the results of ultrasound examination.

3. Assessment of relationship of hormonal dysfunctions in patients with CKD and adipocytokines, markers of renal impairment.

4. To study the effect of renal replacement therapy on thyroid hormones clearance .

5. Investigate hormonal status in patients with CKD after kidney transplantation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date December 31, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patients at CKD 1-5, including renal replacement therapy and renal transplantation

Exclusion Criteria:

- patients with impaired thyroid function before the onset of CKD;

- pregnant women;

- patients with acute diseases;

- patients in the acute phase of comorbid chronic diseases;

- patients in the acute period of myocardial infarction, after acute cerebrovascular accident;

- patients with mental illness;

- patients undergoing treatment for various cancer types.

Study Design


Intervention

Other:
Ultrasound, DXA, hormonal tests
Diagnostic tests in selected groups with investigation of revealed hormonal disorders

Locations

Country Name City State
Belarus Belarusian State Medical University Endocrinology Department Minsk

Sponsors (1)

Lead Sponsor Collaborator
Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hormanal changes in patients with CKD Deviations from reference interval ranges of prolactin, thyroid hormones, PTH and vitamin D and its associations with renal impairment markers Baseline
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