Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-27 @ 9:23 AM
Study NCT ID:
NCT04987450
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2021-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Glucocorticoids on Inflammation and Bone Metabolism in Patients With Glomerular Disease
Sponsor:
Medical University of Lodz
Organization:
Study Overview
Official Title:
Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: