- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01403766
Comparison of Markers of Kidney Function
Comparison of Estimated GFR Using Cystatin C Versus Creatinine in Pediatric Renal Transplant Patients
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Study patients will come in for their surveillance biopsy done as standard of care post-transplant. They we be made NPO at midnight prior to the biopsy per routine. On arrival, they will have standard of care pre-biopsy bloods drawn along with baseline study labs including serum enzymatic creatinine (1mL of blood), cystatin C (1.5 mL of blood), and 1mL of blood collected pre-iohexol infusion. Two IV's will be started, one for iohexol administration and fluids, and the other for blood draws. Study patients will be started on 1x maintenance intravenous fluids. The patient will then have their standard of care protocol biopsy in the ultrasound suite. After the biopsy 5 mL Iohexol (Omnipaque 300) will be administered over 1-2 minutes, with epinephrine, solumedrol, and diphenhydramine on hand in the event of a reaction although this is very unlikely. The patient will be observed and vital signs will be taken 10 minutes post-infusion. After biopsy, maintenance fluids will be continued until completion of the study. Blood for determination of Iohexol levels (1mL) will be drawn at 10, 30, 120, and 300 minutes post iohexol infusion when patient is being observed post biopsy. At completion of the study at 300 minutes post iohexol infusion, serum creatinine (1mL of blood), cystatin C (1.5 mL of blood) will be drawn again. The total volume of blood drawn for the study will be 10mL.
Creatinine (enzymatic method) will be determined on the Olympus system, and Cystatin C (Gentian assay) will be determined on the AU400 Olympus System at the UCLA Department of Pathology and Laboratory Medicine Outreach Laboratory. Iohexol GFR will be determined at the University of Rochester Medical Center in Dr. Schwartz's laboratory. Kidney biopsies will be graded by updated Banff criteria, and reviewed by blinded pathologist.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90095
- University of California, Los Angeles
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Renal transplant patient aged 1 to <19 years old
- Stable allograft function (no history of biopsy proven acute rejection or increase of creatinine of > 10% from baseline in the past 6 months)
- No changes in maintenance immunosuppression in the month before the protocol biopsy
- Subject and/or parent must be able to understand and provide informed consent
Exclusion Criteria:
- Biopsy proven acute rejection in the past 6 months
- Change in maintenance immunosuppression in the month before the protocol biopsy
- Known diabetes mellitus
- Known thyroid dysfunction
- Allergy to Iohexol or other contrast media
- Inability or unwillingness of a participant or their legal guardian to give written informed consent or comply with the study protocol
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Pediatric post-kidney transplant
Patients having standard of care surviellance biopsies.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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The primary outcome measure is a comparison of determination of GFR through three methods: cystatin C (Gentian assay), creatinine (Schwartz and update Schwartz) and iohexol disappearance
Lasso di tempo: Participants will be followed for the duration of the Iohexol GFR measurement (approximately 8 hours) that will take place at the time of surveillance biopsy at either 6 months, 1 or 2 years post-transplant..
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Participants will be followed for the duration of the Iohexol GFR measurement (approximately 8 hours) that will take place at the time of surveillance biopsy at either 6 months, 1 or 2 years post-transplant..
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Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Gentian-Cystatin-UCLA
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 .
Prove cliniche su Insufficienza renale
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National Cancer Institute (NCI)NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group BCompletatoCarcinoma a cellule renali a cellule chiare | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti, Canada, Porto Rico
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National Cancer Institute (NCI)TerminatoCarcinoma a cellule renali a cellule chiare | Carcinoma a cellule renali metastatico | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio IV AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti