Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation

Liver Transplantation Clinical Trial

— DIAMOND  

Official title:

A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti-IL2R Antibody (Basiliximab)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011205
• Other study ID #: PMR-EC-1106
• Secondary ID: 2008-002231-3220
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2009
• Last updated: November 20, 2017
• Start date: September 30, 2009
• Est. completion date: January 4, 2013

Study information

• Verified date: November 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 893
• Est. completion date: January 4, 2013
• Est. primary completion date: January 4, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing orthotopic liver or split liver allograft transplantation

• Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study

Exclusion Criteria:

• Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)

• Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used

• Receiving ABO incompatible graft or a graft from a non heart beating donor

• Ongoing dosing with systemic corticosteroids

• Subjects with systemic infection requiring treatment except viral hepatitis

• Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:

• < 3 nodes

• no node larger than 5 cm

• no metastases

• no vascular tumoral invasion

• Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer

• Subject or donor known to be HIV positive

• Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients

• Pregnant woman or breast-feeding mother

• Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment

• Unlikely to comply with the Visits scheduled in the protocol

• Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator

• Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment

• Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Advagraf
Capsule
• Mycophenolate Mofetil
Solution for infusion
• Basiliximab
IV infusion
• Corticosteroids
IV bolus

Locations

Country	Name	City	State
Argentina	160	Buenos Aires
Austria	001	Innsbruck
Belarus	146	Minsk
Belgium	008	Brussels
Belgium	006	Gent
Belgium	009	Leuven
Belgium	010	Liege
Brazil	163	Sao Paulo
Canada	153	Edmonton
Canada	150	Halifax
Canada	151	London
Canada	152	Montreal
Canada	154	Vancouver
Colombia	169	Bogata
Czechia	147	Prague
Finland	026	Helsinki
France	041	Besancon
France	157	Bordeaux
France	043	Caen
France	031	Creteil
France	039	Lyon
France	045	Marseille
France	158	Montpelier
France	037	Nice
France	035	Paris
France	042	Paris
France	044	Paris
France	038	Strasbourg
France	033	Toulouse
France	034	Villejuif
Germany	056	Berlin
Germany	058	Erlangen
Germany	051	Frankfurt
Germany	055	Gottingen
Germany	057	Hannover
Germany	142	Jena
Germany	053	Kiel
Germany	054	Leipzig
Germany	Site: 156	Mainz
Germany	052	Munster
Germany	060	Regensberg
Germany	059	Tubingen
Hungary	061	Budapest
Ireland	070	Dublin
Italy	073	Bergamo
Italy	075	Bologna
Italy	076	Genova
Italy	077	Naples
Italy	079	Naples
Italy	072	Padova
Italy	074	Rome
Italy	071	Udine
Mexico	Site: 166	Mexico City
Poland	086	Warsaw
Poland	087	Warsaw
Romania	091	Bucharest
Russian Federation	096	Moscow
Russian Federation	097	Moscow
South Africa	148	Johannesburg
Spain	114	A Coruna
Spain	106	Barcelona
Spain	109	Barcelona
Spain	110	Barcelona
Spain	108	Madrid
Spain	115	Madrid
Spain	117	Madrid
Spain	116	Zaragoza
Sweden	126	Gothenberg
Switzerland	131	Zurich
United Kingdom	136	Birmingham
United Kingdom	171	Leeds
United Kingdom	138	London

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Argentina,  Austria,  Belarus,  Belgium,  Brazil,  Canada,  Colombia,  Czechia,  Finland,  France,  Germany,  Hungary,  Ireland,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula		24 weeks
Secondary	Incidence of and time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)		24 weeks
Secondary	GFR at 24 Weeks after transplantation measured by Iothalamate clearance		24 weeks
Secondary	GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula		24 weeks
Secondary	Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula		24 weeks
Secondary	Incidence of and time to first incidence of acute rejection		24 weeks
Secondary	Incidence of and time to first incidence of corticosteroid-resistant acute rejection		24 weeks
Secondary	Overall frequency of acute rejection episodes		24 weeks
Secondary	Incidence of and time to first incidence of biopsy confirmed acute rejection		24 weeks
Secondary	Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection		24 weeks
Secondary	Overall frequency of biopsy confirmed acute rejection episodes		24 weeks
Secondary	Severity of biopsy confirmed acute rejection episodes		24 weeks

External Links

•   Link to results on Astellas Clinical Study Results website