Kidney transplantation is the best treatment for many patients with kidney failure. Sometimes a transplanted kidney is rejected by the patient's immune system. Many types of immune system cells, including B cells, are active in rejection. B cells produce antibodies against anything the body sees as non-self, like germs or a transplanted kidney. Most medicines that help prevent transplant rejection affect cells other than B cells. Belimumab is a medication used to treat a disease called lupus. Belimumab slows development of antibody-producing B cells. This study will test whether belimumab works on parts of the immune system that cause rejection. Twenty to thirty adults getting a kidney transplant will be in this study. Like flipping a coin, a computer will randomly assign half to be given belimumab and half to be given placebo (a fake medicine). Patients and doctors will not know which medicine was assigned until the study is over. A total of 7 doses of study medicine will be given through a vein. One dose will be given during transplant surgery, and the other 6 will be given 2, 4, 8, 12, 16 and 20 weeks after transplant surgery. Usual transplant medicines will also be given. After all of the doses have been given, patients will be watched and tested at 24, 36, and 52 weeks after the transplant surgery. Blood samples will be tested to see what study medicines do to the immune system in transplant patients. If patients get a kidney biopsy, the samples will be tested to see if belimumab had any effect. Patients will be asked many questions to see if they are having any side effects. The study will be done at Addenbrooke's Hospital in Cambridge and Guys \&St Thomas Hospital in London, United Kingdom. A pharmaceutical company, GlaxoSmithKline, is funding the study.
Age range
18 Years – 75 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change From Baseline in naïve B Cells From Baseline to Week 24
Timeframe: Baseline and Week 24
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Timeframe: Up to 1 year
Number of Incidence of All Infections and Serious Infections
Timeframe: Up to 1 year
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52
Timeframe: Week 24 and Week 52
Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52
Timeframe: Week 24 and Week 52
Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52
Timeframe: Week 24 and Week 52
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52
Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52
Timeframe: Baseline, Week 24 and Week 52