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Clinical Trial Technology Development for the Validation of Surrogate Prognostic Markers in Patients With Diabetic Nephropathy

12. februar 2014 opdateret af: Yon Su Kim, Seoul National University Hospital

Worldwide, the most common cause of chronic kidney disease (CKD) and end stage renal disease (ESRD) is diabetes. Unlike the past, in south korea, diabetes account for more than 40% of ESRD. According to WHO reports in 1998, 100 million people had type 2 diabetes in 1997, and there is expected to increase by 300 million people in 2025. In addition, the expected survival time of patients with diabetes increase compared to previous. In the future, ESRD due to type 2 diabetes is expected to have a significant impact on the health industry. Therefore, prevention of progression to CKD and ESRD in diabetic patients is important to aspect of national health and economic problems. How to stop the progression of diabetic nephropathy is part of modern medicine to be solved.

Strict glycemic control, blood pressure regulation, and use of renin-angiotensin system (RAS) blockers inhibit the development and progression of diabetic nephropathy. Microalbuminuria in diabetic patients has been recognized as a predictor of progression of diabetic nephropathy. Thus, the prevention of elevated urinary albumin excretion is an important therapeutic target for the prevention of renal and cardiovascular events.

In patients with diabetes and hypertension, the drugs that block the RAS are used to treat proteinuria, but still a large number of patients with proteinuria are uncontrolled. In addition, ACE inhibitors or ARB agents actually have a limited effect on reducing the risk of cardiovascular or renal outcome. Also, sulodexide or pentoxyphylline which is reducing proteinuria have some weak evidence in terms of efficacy and safety. Therefore, the introduction of new alternative drugs are required.

Already several study reported that calcitriol or paricalcitol in the renal injury model have renopreventive effect. In addition, in diabetic renal injury mice model reported that vitamin D receptor deficiency leads to glomerulosclerosis. Inhibition of the RAS with combination of paricalcitol and RAS inhibitors effectively prevent renal injury in diabetic nephropathy. Recently, Dick de Zeeuw et al reported that addition of paricalcitol to RAS inhibition safely lower residual albuminuria in patients with diabetic nephropathy. Recent studies reported that elevated concentrations of serum markers of the TNFα and Fas-pathways are strongly associated with decreased renal function in diabetic patients. However, the role of these markers in early progressive renal function decline are not clear. Therefore, the objective of this study is to identify the renoprotective effect as an new treatment of activated vitamin D (Calcitriol) indicating the TNF-α-related anti-inflammatory action and to seek the role as an important biomarker that the changes of TNFR in diabetic nephropathy can predict response to treatment.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

276

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 110-744
        • Rekruttering
        • Seoul National University Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Yonsu Kim, Ph.D.
        • Underforsker:
          • Dongki Kim, M.D., Ph.D
        • Underforsker:
          • Sumi Lee, M.D.
      • Seoul, Korea, Republikken
        • Ikke rekrutterer endnu
        • Seoul National University Boramae Medical Center
        • Kontakt:
        • Underforsker:
          • Jungpyo Lee, M.D., Ph.D

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

19 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patients age 19-80 years
  • Clinically proven diabetic nephropathy
  • MDRD eGFR >= 30mL/min/1.73m2
  • Patients with residual urine protein/creatinine ratio >= 200mg/g
  • Adequate blood pressure control as treated systolic blood pressure <=140 or diastolic <=90 mmHg with RAS inhibitor for more than 3months
  • Serum intact PTH <500 mg/dL
  • Serum calcium <10.2 mg/dL
  • Patients who have not been treated vitamin D within the 3months prior to signing the informed consent form

Exclusion Criteria:

  • Patients age <19 years or > 80years
  • Patients with rapidly progressive glomerulonephritis
  • Patients requiring renal replacement therapy immediately
  • Hypercalcemia(Uncorrected serum calcium level >10.2 mg/dL) within recent 3month
  • Malignant hypertension
  • Heart failure (New York Heart Association functional class II to IV or LVEF <40%)
  • Severe chronic obstructive lung disease
  • Decompensated liver disease (ALT >3X upper normal limit)
  • Known allergy or hypersensitivity to vitamin D
  • Current treatment with steroids and/or immunosuppressive agents
  • Active primary malignancy requiring treatment or survival limits less than 2years
  • History of noncompliance to medical regimen
  • Inability to give an informed consent or to cooperate with researchers

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Eksperimentel: Calcitriol
Medicin: Calcitriol
dosage of 0.5mcg administered orally once daily for 12 month

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in renal function with proteinuria
Tidsramme: 12 month after administration
Comparison of in GFR level from baseline Comparison of proteinuria amount checked by random urine protein/creatinine ratio
12 month after administration

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
changes in sTNFR and TNF-related proteins
Tidsramme: 12 months after administration
Comparison of serum TNFR1, TNFR2 levels from baseline
12 months after administration

Samarbejdspartnere og efterforskere

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

Sponsor

Seoul National University Hospital

Efterforskere

  • Studiestol: Yonsu Kim, M.D., Ph.D, Seoul National University Hospital

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. oktober 2012

Primær færdiggørelse (Forventet)

1. april 2014

Datoer for studieregistrering

Først indsendt

21. august 2012

Først indsendt, der opfyldte QC-kriterier

24. august 2012

Først opslået (Skøn)

27. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SNUH-TNFR

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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