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

2. august 2021 opdateret af: Michal Nowicki, Medical University of Lodz

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

40

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Michał Nowicki, Prof. MD.
  • Telefonnummer: + 48 42 2014400
  • E-mail: nefro@wp.pl

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
the change of plasma SIRT-1 level after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of plasma sclerostin level after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of plasma FGF-23 level after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of plasma IL-6 level after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of plasma total calcium level after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of plasma phosphate level after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of plasma PTH level after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of urine albumin/creatinine ratio after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of urine total protein/creatinine ratio after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of urine phosphate/creatinine ratio after glucocorticoids administration
Tidsramme: 30 days
30 days
the change of urine calcium/creatinine ratio after glucocorticoids administration
Tidsramme: 30 days
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of Lodz

Efterforskere

  • Ledende efterforsker: Michał Nowicki, Prof. MD., Department of Nephrology, Hypertension and Kidney Transplantation Medical University of Lodz, Poland

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2018

Primær færdiggørelse (Forventet)

30. juli 2021

Studieafslutning (Forventet)

30. juli 2021

Datoer for studieregistrering

Først indsendt

22. juli 2021

Først indsendt, der opfyldte QC-kriterier

2. august 2021

Først opslået (Faktiske)

3. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RNN/267/17/KE

Plan for individuelle deltagerdata (IPD)

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INGEN

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