Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04439747
• Other study ID #: 20180438
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Chronic Kidney Diseases
• Hyperprolactinemia
• Kidney Diseases
• Metabolic Diseases
• Renal Insufficiency, Chronic
• Thyroid Dysfunction

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

External Links

•   preliminary data