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Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy

22. april 2013 opdateret af: Shanghai University of Traditional Chinese Medicine

Mechanism Research of Traditional Chinese Medicine (the Comprehensive Treatment Regimen) in Treating Idiopathic Membranous Nephropathy by Genomewide Association Studies

The purpose of this study is to analysis the different genotype in the idiopathic membranous nephropathy patients which with different therapeutic outcomes after treated by the Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal markers to assess appropriate treatment approach and the long-term efficacy.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary objective of this study is to looking for the gene level predictors in the patients who suffered from idiopathic membranous nephropathy. And according to the predictors, the clinicians could make a decision which method should be taken on IMN patients, Traditional Chinese Medicine or western medicine, and could get better results.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

80

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina, 200032
        • Rekruttering
        • Shanghai University of Traditional Chinese Medicine
        • Kontakt:

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 til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

idiopathic membranous nephropathy

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of idiopathic membranous nephropathy
  • Chronic Kidney Disease (CKD)≤3 stage（Glomerular Filtration Rate (GFR)≥30ml/min）and 24 hour urinary protein≥3g
  • Voluntarily participated in the study and signed an informed consent

Exclusion Criteria:

  • Combined life-threatening complications such as serious infection
  • Abnormal glucose metabolism
  • Patients with malignant tumors or malignancy , HIV infection and a history of mental illness , acute central nervous system disease , serious gastrointestinal diseases,etc
  • Pregnancy or breast-feeding women
  • Undergoing other clinical trials

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
CR/CTR group
The complete remission group treated by the Comprehensive Treatment Regimen
Medicin: The Comprehensive Treatment Regimen of Traditional Chinese Medicine

①ShenQiMoShen Decoction: which plays vital therapeutic effect in the CTR,the dosage is 150ml per serving and two services per day.Dosage and administration:150ml per time,twice per day

②HuoXueTongMai Capsule : which plays a vital role of promoting blood circulation and removing blood stasis. Its main components are the leeches. Dosage and administration: 4 capsules 3 times daily.

③HeiLiaoDou Particle: which will be prescribed when hypoproteinemia (serum albumin concentration≤30g/L)occurred and should be stopped taking until the serum albumin is above 30g/L. Dosage and administration: 2 packages 3 times daily.

Andre navne:
  • ShenQiMoShen Decoction
  • HuoXueTongMai Capsule
  • HeiLiaoDou Particle
NR/CTR group
The non-remission group treated by the Comprehensive Treatment Regimen
Medicin: The Comprehensive Treatment Regimen of Traditional Chinese Medicine

①ShenQiMoShen Decoction: which plays vital therapeutic effect in the CTR,the dosage is 150ml per serving and two services per day.Dosage and administration:150ml per time,twice per day

②HuoXueTongMai Capsule : which plays a vital role of promoting blood circulation and removing blood stasis. Its main components are the leeches. Dosage and administration: 4 capsules 3 times daily.

③HeiLiaoDou Particle: which will be prescribed when hypoproteinemia (serum albumin concentration≤30g/L)occurred and should be stopped taking until the serum albumin is above 30g/L. Dosage and administration: 2 packages 3 times daily.

Andre navne:
  • ShenQiMoShen Decoction
  • HuoXueTongMai Capsule
  • HeiLiaoDou Particle
CR/IA group
The complete remission group treated by Immunosuppressive Agents
Medicin: The immunosuppressive agents
According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis
Andre navne:
  • Cyclofosfamid
  • Cyclosporin
  • Glukokortikoid
  • Tacrolimus
NR/IA group
The non-remission group treated by Immunosuppressive Agents.
Medicin: The immunosuppressive agents
According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis
Andre navne:
  • Cyclofosfamid
  • Cyclosporin
  • Glukokortikoid
  • Tacrolimus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Genome-wide single-nucleotide-polymorphism of IMN patients treated by the Comprehensive Treatment Regimen or conventional approach
Tidsramme: one year
Screening for single-nucleotide-polymorphism as the prognostic factor for the TCM intervention of IMN patients.
one year

Samarbejdspartnere og efterforskere

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

Sponsor

Shanghai University of Traditional Chinese Medicine

Efterforskere

  • Studieleder: Wang Lin, PHD,MD, Shanghai University of Traditional Chinese Medicine

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

1. december 2010

Primær færdiggørelse (Forventet)

1. august 2013

Studieafslutning (Forventet)

1. august 2013

Datoer for studieregistrering

Først indsendt

8. januar 2013

Først indsendt, der opfyldte QC-kriterier

23. februar 2013

Først opslået (Skøn)

26. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. april 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ShanghaiMEC-2011
  • 11YZ65 (Andet bevillings-/finansieringsnummer: Shanghai Municipal Education Commission)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Panama

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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