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A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).

8. dubna 2016 aktualizováno: Hoffmann-La Roche

Relationships Between Pharmacokinetic and Pharmacodynamic Strategies for Assessment of the Risks for Acute Rejection and Side Effects of Mycophenolate Mofetil

This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

45

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Itálie
      • Bari, Itálie, 70124
      • Brescia, Itálie, 25123
      • Coppito, Itálie, 67100
      • Napoli, Itálie, 80131
      • Roma, Itálie, 00168
      • Torino, Itálie, 10126
      • Verona, Itálie, 37126

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age
  • Patients undergoing primary kidney transplantation

Exclusion Criteria:

  • Recipients of multiple organ transplants
  • Prior therapy with CellCept
  • Presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin
  • Active peptic ulcer or active serious digestive system disease that may affect the absorption of CellCept

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Mycophenolate Mofetil Monotherapy
Participants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
Lék: mycophenolate mofetil
1 g PO BID for 24 weeks
Ostatní jména:
  • CellCept
Lék: antibody induction
According to manufacturer recommendation
Lék: Cyclosporine
According to manufacturer recommendation
Lék: corticosteroid
According to manufacturer recommendation

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Acute Rejection
Časové okno: Day 1, Weeks 2, 4, 12, 24, and 28
Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy.
Day 1, Weeks 2, 4, 12, 24, and 28
Time to Rejection
Časové okno: Day 1, Weeks 2, 4, 12, 24, and 28
The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection.
Day 1, Weeks 2, 4, 12, 24, and 28
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)
Časové okno: Day 1, Weeks 2, 4, 12, 24, and 28
BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (>)25% of parenchyma affected, and foci of moderate tubulitis with >4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with >25% parenchyma affected, and foci of severe tubulitis with >10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising >25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells.
Day 1, Weeks 2, 4, 12, 24, and 28

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Graft Loss
Časové okno: Day 1, Weeks 2, 4, 12, 24, and 28
An allograft was presumed to be lost if a participant started dialysis and was not able to subsequently be removed from dialysis.
Day 1, Weeks 2, 4, 12, 24, and 28
Percentage of Participants Surviving
Časové okno: Day 1, Weeks 2, 4, 12, 24, and 28
Day 1, Weeks 2, 4, 12, 24, and 28
Total Mycophenolate Acid (MPA) by Visit and Timepoint
Časové okno: Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits
Drug quantification of total MPA (micrograms per milliliter [mcg/mL]) in the plasma was measured at time (T) = 0 minutes (min), 40 mins, and 120 mins.
Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits
Free MPA (mcg/mL) by Visit
Časové okno: Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits
Drug quantification of free MPA in the plasma was measured at T = 0, 40, and 120 mins.
Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits
MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit
Časové okno: Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)
The AUC0-12 of MPA was estimated on the validated limited sampling strategy, AUC (milligrams multiplied by height over liter [mg.h/L]) = 7.182 + 4.607 multiplied by (*) concentration at 0 minutes (C0)+ 0.998 * the concentration at 40 minutes (C0.67) + 2.149 * the concentration at 120 minutes (C2).
Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)
Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint
Časové okno: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IMPDH activity in peripheral blood mononuclear cells (PBMCs) was measured at 2 timepoints per visit, 0 and 120 minutes and presented in enzyme units. The unit of measure of enzyme activity is "U". One U is defined as the amount of the enzyme that produces a certain amount of enzymatic activity that is, the amount that catalyzes the conversion of 1 micro mole of substrate per minute under pre-specified conditions (temperature, pH).
BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IMPDH Expression I by Visit and Timepoint
Časové okno: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IMPDH I gene expression was measured by real time polymerase chain reaction (QRT-PCR) based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of messenger ribonucleic acid (mRNA) copies per cell (copies/cell).
BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IMPDH Expression II by Visit and Timepoint
Časové okno: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IMPDH II gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.
BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
Interleukin 8 (IL-8) Expression by Visit and Timepoint
Časové okno: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IL-8 gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.
BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint
Časové okno: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
TNF gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.
BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
Percentage of Participants With Infection
Časové okno: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
Infections were graded according to the World Health Organization (WHO) worst grade observed.
BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
Percentage of Participants With Gastrointestinal Toxicities
Časové okno: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit)
Gastrointestinal adverse events (AEs) according to WHO worst grade observed.
BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit)
Percentage of Participants With Hematologic Toxicity
Časové okno: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
Hematological toxicities graded according to WHO worst grade observed (Grade 1=mild, Grade 2=moderate).
BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity
Časové okno: BL and Weeks 2, 4, 12, and 24
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
BL and Weeks 2, 4, 12, and 24

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hoffmann-La Roche

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. prosince 2006

Primární dokončení (Aktuální)

1. září 2008

Dokončení studie (Aktuální)

1. září 2008

Termíny zápisu do studia

První předloženo

3. února 2011

První předloženo, které splnilo kritéria kontroly kvality

8. února 2011

První zveřejněno (Odhad)

9. února 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

12. května 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. dubna 2016

Naposledy ověřeno

1. dubna 2016

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ML19835

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