- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04987450
Effect of Glucocorticoids on Inflammation and Bone Metabolism in Patients With Glomerular Disease
Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Michał Nowicki, Prof. MD.
- Telefonnummer: + 48 42 2014400
- E-post: nefro@wp.pl
Studer Kontakt Backup
- Navn: Katarzyna Pęczek, Dr
- E-post: katarzyna.peczek90@gmail.com
Studiesteder
-
-
-
Łódź, Polen
- Rekruttering
- Medical University of Lodz, Poland
-
Ta kontakt med:
- Ireneusz Staroń, Study Chair
- E-post: ireneusz.staron@umed.lodz.pl
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
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.
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michał Nowicki, Prof. MD., Department of Nephrology, Hypertension and Kidney Transplantation Medical University of Lodz, Poland
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Betennelse
- Fysiologiske effekter av legemidler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Nevrobeskyttende midler
- Beskyttende agenter
- Prednisolon
- Metylprednisolonacetat
- Metylprednisolon
- Metylprednisolon Hemisuccinat
- Prednisolonacetat
- Prednisolon hemisuccinat
- Prednisolonfosfat
- Prednison
Andre studie-ID-numre
- RNN/267/17/KE
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Methylprednisolone, prednisone
-
Tel-Aviv Sourasky Medical CenterUkjentCat-scratch sykdom | Bartonella-infeksjonerIsrael
-
University of South FloridaNational Heart, Lung, and Blood Institute (NHLBI); National Institute of... og andre samarbeidspartnereAktiv, ikke rekrutterendeVaskulitt | Granulomatose med polyangiitt | Wegener GranulomatoseForente stater
-
Rabin Medical CenterUkjent
-
University of Alabama at BirminghamNational Institute of Neurological Disorders and Stroke (NINDS)FullførtMyasthenia GravisThailand, Canada, Tyskland, Italia, Nederland, Brasil, Forente stater, Argentina, Australia, Chile, Japan, Mexico, Polen, Portugal, Sør-Afrika, Spania, Taiwan, Storbritannia
-
Health Science Center of Xi'an Jiaotong UniversityUkjentFokal segmentell glomeruloskleroseKina
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI); National Institute of... og andre samarbeidspartnereAktiv, ikke rekrutterendeGranulomatose med polyangiittForente stater, Canada
-
Prof. Tony hayek MDFullførtDiabetes | Aterosklerose | DyslipidemierIsrael
-
Hoffmann-La RocheFullførtAvansert follikulært lymfomTyskland, Brasil, Storbritannia, Spania, Japan, Forente stater, Nederland
-
Mundipharma Research LimitedAvsluttetPolymyalgia RheumaticaStorbritannia