Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
30 giugno 2015 aggiornato da: Veloxis Pharmaceuticals
Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
36
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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San Diego, California, Stati Uniti, 92123
- Clinical Investigative Site 000015
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San Francisco, California, Stati Uniti, 94115
- Clinical Investigative Site 000012
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Clinical Investigative Site 00004
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Florida
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Tampa, Florida, Stati Uniti, 33606
- Clinical Investigative Site 000002
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40536-0293
- Clinical Investigative Site 000005
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- Clinical Investigative Site 000009
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New Jersey
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Livingston, New Jersey, Stati Uniti, 07039
- Clinical Investigative Site 000010
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New York
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Buffalo, New York, Stati Uniti, 14215
- Clinical Investigative Site 000011
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New York, New York, Stati Uniti, 10016
- Clinical Investigative Site 00006
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Ohio
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Cleveland, Ohio, Stati Uniti, 44095
- Clinical Investigative Site 00008
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Clinical Investigative Site 00003
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Texas
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Dallas, Texas, Stati Uniti, 75246
- Clinical Investigative Site 000013
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22903
- Clinical Investigative Site 00001
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion criteria
- Give written consent
- Male and female subjects between the ages of 18 and 70 years, inclusive
- Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor
- WOCBP must have a negative pregnancy test
- Must have negative cross-match test and be ABO-compatible
- Must be able to swallow tablets and capsules
Exclusion criteria
- Recipients of any previous nonrenal or concurrent transplant
- Have panel reactive antibody >50%
- Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2
- History of alcohol abuse with less than 6 months of sobriety
- History of recreational drug abuse with less than 6 months of documented abstinence
- Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation)
- WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
- Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method
- Oral temperature (prior to study drug dosing) of 38.0ºC or higher
- CS active infections (eg, those requiring hospitalization, or as judged by the Investigator)
- Known hereditary immunodeficiency
- Malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ
- Expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide
- Any psychiatric or medical condition that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Clinically symptomatic CHF or documented EJF of less than 45%
- Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension
- Enrolled in another investigational drug or device study, or who are less than 30 days since discontinuing
- Laboratory variables that are abnormal (outside laboratory reference range) and CS
- Positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab)
- Subjects who have had primary focal segmental glomerulosclerosis
- Donor parameters must not include any of the following known conditions:
Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of malignant disease (current or historical) Cold ischemia time >30 hours Non-heart-beating donor
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: LCP-Tacro
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
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Tacrolimus
Altri nomi:
|
|
Comparatore attivo: Prograf
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
|
Tacrolimus
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 1 days
|
The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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1 days
|
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 14 days
|
The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
|
14 days
|
|
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 28 days
|
The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
|
28 days
|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 1 days
|
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
|
1 days
|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 14 days
|
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
|
14 days
|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 28 days
|
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
|
28 days
|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 1 days
|
The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
|
1 days
|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 14 days
|
The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
|
14 days
|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 28 days
|
The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
|
28 days
|
|
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 14 days
|
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
|
14 days
|
|
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Lasso di tempo: 28 days
|
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
|
28 days
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
Lasso di tempo: 14 days
|
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
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14 days
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Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
Lasso di tempo: 28 days
|
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.
|
28 days
|
|
Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
Lasso di tempo: 14 days
|
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
|
14 days
|
|
Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
Lasso di tempo: 28 days
|
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.
|
28 days
|
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Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
Lasso di tempo: 30 days
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The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.
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30 days
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: William Polvino, MD, Veloxis Pharmaceuticals
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2012
Completamento primario (Effettivo)
1 marzo 2013
Completamento dello studio (Effettivo)
1 maggio 2013
Date di iscrizione allo studio
Primo inviato
14 agosto 2012
Primo inviato che soddisfa i criteri di controllo qualità
14 agosto 2012
Primo Inserito (Stima)
16 agosto 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
7 luglio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 giugno 2015
Ultimo verificato
1 giugno 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LCP-Tacro 2019
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 .