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

NCT04987450 | Unknown

• 1 other identifier: RNN/267/17/KE
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Glomerular Disease

Keywords

glucocorticoids; primary glomerular disease; sirtuin-1; sclerostin

Outcome Measures

Primary Outcomes (11)

• the change of plasma SIRT-1 level after glucocorticoids administration

  30 days

• the change of plasma sclerostin level after glucocorticoids administration

  30 days

• the change of plasma FGF-23 level after glucocorticoids administration

  30 days

• the change of plasma IL-6 level after glucocorticoids administration

  30 days

• the change of plasma total calcium level after glucocorticoids administration

  30 days

• the change of plasma phosphate level after glucocorticoids administration

  30 days

• the change of plasma PTH level after glucocorticoids administration

  30 days

• the change of urine albumin/creatinine ratio after glucocorticoids administration

  30 days

• the change of urine total protein/creatinine ratio after glucocorticoids administration

  30 days

• the change of urine phosphate/creatinine ratio after glucocorticoids administration

  30 days

• the change of urine calcium/creatinine ratio after glucocorticoids administration

  30 days

Study Arms (1)

Study population

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.

Drug: Methylprednisolone, prednisone

Interventions

Methylprednisolone, prednisone DRUG

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.

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with primary glomerular disease who are diagnosed and hospitalized in Nephrology Department in Łódź.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Medical University of Lodz, Poland

Lodz, Poland

RECRUITING

MeSH Terms

Conditions

Sclerosteosis

Interventions

Methylprednisolone; Prednisone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Study Officials

• Michał Nowicki, Prof. MD.

  Department of Nephrology, Hypertension and Kidney Transplantation Medical University of Lodz, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michał Nowicki, Prof. MD.

CONTACT

+ 48 42 2014400; nefro@wp.pl

Katarzyna Pęczek, Dr

CONTACT

katarzyna.peczek90@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 3, 2021
• Study Start: October 1, 2018
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)