EUCTR2012-004308-36-GB
Active, not recruiting
Not Applicable
A randomized controlled clinical trial to determine if a combined screening /treatment programme can prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies. - OuTSMART
Kings College London0 sitesDecember 10, 2012
ConditionsRenal Transplant recipients with HLA antibodies, who are at increased risk of graft dysfunction and graft failureMedDRA version: 14.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865Therapeutic area: Body processes [G] - Immune system processes [G12]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Transplant recipients with HLA antibodies, who are at increased risk of graft dysfunction and graft failure
- Sponsor
- Kings College London
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written and witnessed informed consent to participate.
- •Renal transplant recipients \>1 year post\-transplantation, male or female
- •Aged 18\-70 years
- •Estimated glomerular filtration rate (eGFR by 4 variable MDRD) of \=30\.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 3000
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 3000
Exclusion Criteria
- •Recipient requiring HLA desensitisation to remove antibody for a positive XM transplant
- •Recipient known already to have HLA antibody WHO HAS RECEIVED specific intervention for that antibody or for CAMR / chronic rejection
- •Recipient of additional solid organ transplants (e.g. pancreas, heart, etc).
- •History of malignancy in previous 5 years (excluding non\-melanomatous tumours limited to skin)
- •HBsAg\+,HBcAb\+, HepC\+ or HIV\+ recipient (on test performed within previous 5 years)
- •History of acute rejection requiring escalation of immunosuppression in the 6 months prior to screening.
- •Patient enrolled in any other studies involving administration of another IMP at time of recruitment
- •The following exclusion criteria are based on information contained within the SMPcs of the IMPs
- •History of an ongoing or previous infection (no time limit) that would prevent optimization of immunosuppression, including ocular Herpes simplex.
- •Known hypersensitivity to any of the IMPs
Outcomes
Primary Outcomes
Not specified
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