Effect of Glucocorticoids on Inflammation and Bone Metabolism in Patients With Glomerular Disease

Glomerular Disease Clinical Trial

Official title:

Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987450
• Other study ID #: RNN/267/17/KE
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2021
• Source: Medical University of Lodz
• Contact: Michal Nowicki, Prof. MD.
• Phone: + 48 42 2014400
• Email: nefro[@]wp.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to assess the influence of high doses of intravenous corticosteroids on plasma inflammation and bone markers in patients with primary glomerular disease. The study would include 40 patients with chronic kidney disease. The main inclusion criterion is clinical and histopathological diagnosis of primary glomerular disease and urine protein excretion >2.0 g/24h. The exclusion criteria include secondary glomerular disease, acute kidney injury, acute or chronic inflammation, history of non-compliance.

Description:

Glucocorticoids are one of the most widely used classes of drugs to treat inflammatory and autoimmune diseases. They increase formation of osteoclasts and enhance bone resorption thereby increasing risk of bone fractures and osteoporosis.

Sirtuin-1(SIRT-1) belongs to family of proteins involved in protection against inflammation and oxidative stress. A role of SIRT-1 in regulation of bone metabolism during high-dose steroid therapy is unknown.

The study protocol was approved by the local Bioethics Committee and the study is conducted according to the Declaration of Helsinki. Adult patients with the previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings are included.

Plasma concentration of SIRT-1, interleukin-6 (IL-6), fibroblast growth factor 23 (FGF-23), sclerostin, calcium, phosphate, parathormone (PTH) and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings

• an estimated glomerular filtration rate =15 ml/min/1.73m2

• proteinuria =2.0 g/24h

Exclusion Criteria:

• secondary glomerular disease

• acute kidney injury

• acute or chronic inflammation

• malignancy

• uncontrolled hypertension with systolic blood pressure higher than 160 mmHg

• symptomatic hypotension

• advanced heart failure

• history of non-compliance, dementia or depression

Related Conditions & MeSH terms

• Glomerular Disease
• Inflammation

Intervention

Drug:
• Methylprednisolone, prednisone
The patients receive intravenous pulses of methylprednisolone 20-30 mg/kg/day for three consecutive days followed by oral prednisone 0.8-1.0 mg/kg/day.

Locations

Country	Name	City	State
Poland	Medical University of Lodz, Poland	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of plasma SIRT-1 level after glucocorticoids administration		30 days
Primary	the change of plasma sclerostin level after glucocorticoids administration		30 days
Primary	the change of plasma FGF-23 level after glucocorticoids administration		30 days
Primary	the change of plasma IL-6 level after glucocorticoids administration		30 days
Primary	the change of plasma total calcium level after glucocorticoids administration		30 days
Primary	the change of plasma phosphate level after glucocorticoids administration		30 days
Primary	the change of plasma PTH level after glucocorticoids administration		30 days
Primary	the change of urine albumin/creatinine ratio after glucocorticoids administration		30 days
Primary	the change of urine total protein/creatinine ratio after glucocorticoids administration		30 days
Primary	the change of urine phosphate/creatinine ratio after glucocorticoids administration		30 days
Primary	the change of urine calcium/creatinine ratio after glucocorticoids administration		30 days