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

Last updated: August 2, 2021
Sponsor: Medical University of Lodz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Focal Segmental Glomerulosclerosis

Treatment

N/A

Clinical Study ID

NCT04987450
RNN/267/17/KE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • previous diagnosed primary glomerular disease based on both clinical and renal biopsyfindings
  • an estimated glomerular filtration rate ≥15 ml/min/1.73m2
  • proteinuria ≥2.0 g/24h

Exclusion

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

Study Design

Total Participants: 40
Study Start date:
October 01, 2018
Estimated Completion Date:
July 30, 2021

Study 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.

Connect with a study center

  • Medical University of Lodz, Poland

    Łódź,
    Poland

    Active - Recruiting

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