- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03968588
Standard- Versus Reduced-dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Renal Transplantation
Comparative Clinical Study of Reduced Dose of Tacrolimus and Standard Dose of Mycophenolate Mofetil vs. Conventional Dose of Tacrolimus and Reduced Dose of Mycophenolate Mofetil in De Novo Renal Transplant Recipients
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
A prospective, multicenter, open-label, randomized and parallel-group clinical trial was conducted at four transplant centers in Korea. The total sample size was 108 and eligible patients were randomly assigned in a 1:1 ratio to either study or control group. For six months study period, graft function, the incidence of efficacy failure and adverse events were compared.
The total sample size was 108 and eligible patients were randomly assigned in a 1:1 ratio to either study or control group: The study group (reduced-dose tacrolimus + standard-dose MMF) or the control group (standard-dose tacrolimus + reduced-dose MMF). Restricted block randomization was applied to this study and both the enrolled subjects and care providers were blinded until randomization was done. A difference in the mean estimated glomerular filtration rates (eGFR) of 16 mL/min/1.73m2 was considered a clinically meaningful margin of non-inferiority. A sample size of 108 for both groups was calculated for the primary endpoint by assuming a significance level of 0.025 with a power of at least 95% and adjusted for a potential dropout rate of 20%.
The primary efficacy endpoint was the renal graft function assessed with eGFR by MDRD formula at 6 months post-transplant. The secondary endpoints included (1) the incidence of treatment failure that included biopsy-confirmed acute rejection (BCAR), graft loss, death, or loss to follow-up until 6 months post-transplant; (2) recipients and grafts' survival rates; (3) 24-hour urine proteinuria and creatinine clearance at 6 months post-transplant. Recipients with clinical findings suggestive of acute rejection underwent biopsies before initiation or within 48 hours of anti-rejection therapy and biopsy specimens were graded according to Banff Classification criteria.
Safety endpoints included (1) all adverse event defined as any medical occurrence including worsening of a preexisting medical condition; (2) opportunistic infections; (3) malignancies; (4) abnormal laboratory findings; and (5) any abnormal physical findings or vital signs. Severe adverse events were defined as any adverse events with undesirable signs, symptoms, or medical conditions that met any one of the following criteria: 1) was fatal or life-threatening, 2) resulted in persistent or significant disability/incapacity, 3) required hospitalization or the prolongation of existing hospitalization, 4) was a congenital anomaly/birth defect, or 5) was an important medical event that might deteriorate the patient and require medical or surgical intervention to prevent one of the other outcomes listed above.18 All adverse events were coding using WHOART 2009 version.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
-
Jeonju, Korea, Republiken av
- Chonbuk National University Hospital
-
Seoul, Korea, Republiken av
- Samsung Medical Center
-
Seoul, Korea, Republiken av
- Gangnam Severance Hospital
-
Suwon, Korea, Republiken av
- Ajou University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Recipients (aged 20-65) of a single (first or second) renal allograft from living or deceased donor.
Exclusion Criteria:
- comprised of recipients with multiple organ transplants
- double kidney transplant or organs donated after cardiac death
- recipients previously organ transplanted except kidney
- ABO-incompatible transplants
- recipients with antibodies against the human leukocyte antigens of the donor organ
- history of malignancy in the previous 5 years (except successfully treated localized non-melanoma skin cancer and thyroid cancer)
- leukocyte counts of less than 2,500 per μL, or neutrophils less than 1,500 per μL, or platelets less than 50,000 per μL
- evidence of active systemic infection requiring the use of antibiotics, human immunodeficiency virus infection, or chronic active hepatitis B or C
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: reduced-dose tacrolimus + standard-dose MMF
Tacrolimus dose was individually adjusted with a target trough blood level of between 3ng/mL and 8ng/mL throughout the study period (6 months after transplantation).
MMF started within 72 hours after transplantation and the dose of MMF was 1.5~2.0g
per day.
|
tacrolimus target trough blood level: 3~8ng/mL MMF dose: 1.5~2g/d
Andra namn:
|
Aktiv komparator: standard-dose tacrolimus + reduced-dose MMF
Control group, target trough blood level was between 5ng/mL and 15ng/mL throughout the study period.
MMF dose was 0.5~1g per day and MMF started within 72 hours after transplantation.
|
tacrolimus target trough blood level: 5~15ng/mL MMF dose: 0.5~1g/d
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
renal graft function
Tidsram: 6 months post-transplant
|
assessed with eGFR by MDRD formula
|
6 months post-transplant
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
incidence of treatment failure
Tidsram: 6 months post-transplant
|
biopsy-confirmed acute rejection (BCAR), graft loss, death, or loss
|
6 months post-transplant
|
recipients and grafts' survival rates
Tidsram: 6 months post-transplant
|
recipients and grafts' survival rates
|
6 months post-transplant
|
24-hour urine proteinuria and creatinine clearance
Tidsram: 6 months post-transplant
|
24-hour urine proteinuria and creatinine clearance
|
6 months post-transplant
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Chang-Kwon Oh, M.D, Department of surgery, Ajou University School of Medicine
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antibakteriella medel
- Antibiotika, antineoplastiska
- Antituberkulära medel
- Antibiotika, Antituberkulära
- Calcineurin-hämmare
- Takrolimus
- Mykofenolsyra
Andra studie-ID-nummer
- 062KTP14-1C
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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