A study for people who have had a kidney transplant to see the benefits and risks of taking belatacept instead of their current anti-rejection medicine.
- Conditions
- Maintenance of renal transplant recipientsMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2012-001314-42-AT
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 446
1) Signed Written Informed Consent a) The subject or legal
representative is willing to provide signed written informed consent 2)
Target Population a) Adult recipients of a renal allograft from a living
donor or a deceased donor between 6-60 mos prior to enrollment. b)
Receiving a stable regimen of CNI (CsA or TAC), with MMF or ECMPS/
MPA and daily corticosteroids for = 1 calendar month prior to
randomization. CNI trough (C0) levels must be in the range of 50-250 ng/ml for CsA and 4-11 ng/ml for TAC [with regard CNI therapy:
receiving a stable regimen specifically refers to maintaining a stable
level of exposure to CsA or TAC within the protocol-specified ranges, and
not to maintaining a stable dose, per se. Thus changes to the CNI dose
made during the Screening period to maintain stable exposure do not
exclude prospective subjects from study participation, so long as their
trough levels remain within the protocol-specified range.] c) Renal
function must have remained stable during the 12 week period prior to
Screening, in the opinion of the investigator and according to the
following criteria:
C1) Absence of new onset proteinuria during the 12-week period prior
to enrollment, as documented by = 1+ protein by dipstick or a randomvoided
urinary protein/creatinine ratio = 0.3 mg protein/mg creatinine
(= 34 mg protein/mmol creatinine) in a patient without previously
diagnosed proteinuria and in the absence of intercurrent illness.
C2) In patients with pre-existing proteinuria (proteinuria known to have
been present prior to the 12-week period before enrollment), urinary
protein excretion at the time of the Screening evaluation must be:
- = 500 mg/24 hours OR the random urinary protein-to-creatinine ratio
(UPr/Cr) must be = 0.5:1 mg protein/mg creatinine (= 56.5 mg
protein/mmol creatinine) at the Screening evaluation in patients with a
history of diabetes mellitus; or
- = 1,000 mg/24 hours OR the random urinary protein-to-creatinine
ratio must be = 1.0:1 mg protein/mg creatinine (= 113 mg
protein/mmol/creatinine) in non-diabetic patients. d) The calculated
GFR (cGFR) must be = 30 and = 75 mL/min/1.73 m2, as calculated using
the 4-variable MDRD equation 30, on two occasions: once at the
Screening evaluation and at one additional time point between 2 and 12
weeks prior to the Screening evaluation. If a historical cGFR value is not
available, then a second cGFR must be obtained at least 2 weeks later
during the Screening period. Calculated results for cGRF should be
rounded to the nearest whole number based upon conventional rounding
rules. NOTE: Both serum creatinine determinations should be from the
same laboratory unless both labs use IDMS-referenced assays. e)
Negative testing for TB by an interferon gamma release assay (IGRA)
such as QuantiFERON®-TB Gold test or T- Spot®-TB test, prior to
randomization. 3) Age and Reproductive Status. a)Men and women,
ages 18 - 75 inclusive.
Women of childbearing potential (WOCBP) must use highly effective
methods of birth control to avoid pregnancy throughout the study and
for up to 8 weeks after the study in such a manner that the risk of
pregnancy is minimized. Please note: that according to the US product
information for MMF or EC-MPS/MPA, two reliable forms of contraception
must be used simultaneously unless abstinence is the chosen method
(see package insert). Acceptable methods of highly effective birth
control include: • Condom with spermicide
Recipients with EBV serostatus negative or unknown; History of any of
the following: treated for biopsy proven AR(BPAR) w/i 3 calendar mos
prior to enrollment; Antibody mediated AR; Recurrent AR in the current
allograft; Banff 97 Grade IIA or greater AR (or equivalent), steroid
resistant AR or treatment with lymphocyte-depleting agents,
plasmapheresis, or rituximab for AR since the time of transplantation of
the current allograft; Subjects with previous graft loss due to BPAR;
Subjects with a positive T-cell lymphocytotoxic cross match; Geneticallyidentical
donor recipient pairs (ie identical twins); Donor age < 10 yrs;
Subjects with underlying renal disease of: Primary focal segmental
glomerulosclerosis, Type I or II membranoproliferative
glomerulonephritis, Atypical hemolytic uremic syndrome (HUS) /
thrombotic thrombocytopenic purpura (TTP). If subject has ESRD of
unknown etiology and/or has no histologically-confirmed diagnosis, the
subject may be enrolled into the study as long as, in the opinion of the
investigator, the overall history and clinical findings are not consistent
with likely diagnosis of underlying primary focal segmental
glomerulosclerosis, Type I or II membranoproliferative
glomerulonephritis, or atypical HUS/TTP; Subjects with prior non-renal
solid organ transplant (subjects undergoing kidney re-transplantation
are eligible pending other study criteria being met), or subjects
undergoing multi-organ transplants (eg kidney-pancreas) or subjects
deemed likely to have a second solid organ or cell transplant (eg
pancreas or islet transplant) in the next 3 years by the investigator;
Subjects receiving a concurrent solid organ (heart, liver, pancreas) or
cell (islet, bone marrow, stem cell) transplant; Subjects receiving paired
kidneys (dual or en bloc kidney transplants); Subjects who are or whose
allograft donor was known hepatitis C antibody-positive or polymerase
chain reaction (PCR)-positive for hepatitis C; Subjects who are or whose
allograft donor was known hepatitis B surface antigen-positive or PCRpositive
for hepatitis B; Subjects and recipients of a graft from a donor
with known human immunodeficiency virus (HIV) infection; Subjects
with any active infection [including but not limited to cytomegalovirus
CMV), BK or Epstein-Barr virus (as determined by dection of quantifiable
viral loads in plasma), BKV associated nephropathy, CMV retinitis, CMV
colitis, tuberculosis, etc.]; Subjects with history of active or untreated
latent tuberculosis (TB) or radiographic finding consistent with active
TB; Subjects must be screened for active and latent tuberculosis prior to
entry into the study. Subjects must have a negative chest x-ray
(posterior-anterior and lateral views) within the last 6 calendar months
prior to screening and a negative IGRA test (such as QuantiFERON®-TB
Gold test or T- Spot®- TB) done at screening by the central laboratory. If
equipment for incubation prior to shipment to central lab is not available
at the site, a local lab IGRA test is acceptable (Refer to Table 5.1-1);
Subjects whose life expectancy is severely limited by disease state or
other underlying medical condition; Subjects with a history of cancer
(other than non-melanoma skin cell cancers cured by local resection)
within the last 5 years; Female subjects who had a breast cancer
screening that is suspicious for malignancy, and in whom the possibility
of malignancy cannot be reasonably exclu
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method