- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01673204
Clinical Trial Technology Development for the Validation of Surrogate Prognostic Markers in Patients With Diabetic Nephropathy
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Seoul, Corea, Repubblica di, 110-744
- Reclutamento
- Seoul National University Hospital
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Contatto:
- Yonsu Kim, M.D., Ph.D
- Numero di telefono: 82-2-2072-2264
- Email: yonsukim@snu.ac.kr
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Contatto:
- Dongki Kim, M.D., Ph.D
- Numero di telefono: 82-2-2072-2303
- Email: dkkim73@gmail.com
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Investigatore principale:
- Yonsu Kim, Ph.D.
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Sub-investigatore:
- Dongki Kim, M.D., Ph.D
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Sub-investigatore:
- Sumi Lee, M.D.
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Seoul, Corea, Repubblica di
- Non ancora reclutamento
- Seoul National University Boramae Medical Center
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Contatto:
- Jungpyo Lee, M.D., Ph.D
- Numero di telefono: 82-2-870-2261
- Email: kjwa1@medimail.co.kr
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Sub-investigatore:
- Jungpyo Lee, M.D., Ph.D
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: Placebo
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Sperimentale: Calcitriol
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dosage of 0.5mcg administered orally once daily for 12 month
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes in renal function with proteinuria
Lasso di tempo: 12 month after administration
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Comparison of in GFR level from baseline Comparison of proteinuria amount checked by random urine protein/creatinine ratio
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12 month after administration
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
changes in sTNFR and TNF-related proteins
Lasso di tempo: 12 months after administration
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Comparison of serum TNFR1, TNFR2 levels from baseline
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12 months after administration
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Collaboratori e investigatori
Investigatori
- Cattedra di studio: Yonsu Kim, M.D., Ph.D, Seoul National University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urologiche
- Malattie del sistema endocrino
- Complicanze del diabete
- Diabete mellito
- Malattie renali
- Nefropatie diabetiche
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Micronutrienti
- Modulatori di trasporto a membrana
- Vitamine
- Agenti di conservazione della densità ossea
- Ormoni e agenti regolatori del calcio
- Agenti vasocostrittori
- Agonisti dei canali del calcio
- Calcitriolo
Altri numeri di identificazione dello studio
- SNUH-TNFR
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .