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

Medical University of Lodz

Status: Unknown

Conditions: Glomerular Disease

Treatments: Drug: Methylprednisolone, prednisone

Study type: Observational

Funder types: Other

Identifiers

NCT04987450

RNN/267/17/KE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Study population

Description:

Plasma levels of SIRT-1, IL-6, FGF-23, sclerostin, calcium, phosphate, PTH and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous daily 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.

Treatment:

Drug: Methylprednisolone, prednisone