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-SE
- 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 EC-MPS/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 random-voided 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; • Diaphragm and 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; Genetically-identical 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 PCR-positive 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 excluded following additional clinical, laboratory
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