Advertisement

Topics

Efficacy of Rituximab in Acute Cellular Rejection in Renal Transplant Patients

2014-08-27 03:13:54 | BioPortfolio

Summary

Acute kidney allograft rejection is the major cause for a loss of graft function and has a negative impact on long-term graft survival. Anti-rejection therapy traditionally focuses on T cell-mediated mechanisms of renal allograft rejection. However, available agents that affect T-cell pathways have only little impact on long-term graft survival. There is increasing evidence that B-cells play an important role in acute transplant rejections. CD20+ B cell infiltrates in acute T-cell mediated rejections are frequent and correlate with a worse response to conventional anti-rejection treatment and an increased risk of graft loss. In one pilot study, supported by several case reports, a beneficial effect of Rituximab for the treatment of acute rejection episodes with intrarenal B-cell infiltrates was shown. However, despite the promise of these observations solid evidence is required before incorporating this treatment option into a general treatment recommendation.

In a multicenter randomized placebo controlled double blind phase III trial the investigators want to demonstrate that Rituximab in addition to standard treatment with steroid-boli is superior to the standard treatment alone regarding long-term kidney function. If the proposed study proves that Rituximab treatment of acute rejections is beneficial for the long-term allograft function, the conventional rejection therapy needs to be revised to this novel concept of B- cell targeting

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Acute Cellular Rejection

Intervention

Rituximab, Placebo

Location

Hannover Medical School
Hannover
Lower Saxony
Germany
30625

Status

Not yet recruiting

Source

Hannover Medical School

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:54-0400

Clinical Trials [1713 Associated Clinical Trials listed on BioPortfolio]

Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

Acute cellular rejection is relatively common after liver transplantation, typically does not affect graft survival, and is not associated with the development of chronic rejection. Acute ...

Rituximab for Prevention of Rejection After Renal Transplantation

Our standard immunosuppressive treatment after renal transplantation is a combination of tacrolimus, mycophenolate mofetil, and prednisolone. With this regimen the incidence of acute rejec...

Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab

Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic ...

Trial of Rituximab Given Pre-Transplant to Sensitised Live Donor Kidney Recipients

About one third of prospective kidney transplant recipients have antibodies in their blood directed against the tissues of their only available kidney donor. Recently, "desensitisation" tr...

Metabolite Biomarkers Related to Acute Rejection in Kidney Transplantation

The development of acute rejection can only be considered in cases with increasing serum creatinine in patients with kidney transplantation. However, the serum creatinine itself is not spe...

PubMed Articles [12410 Associated PubMed Articles listed on BioPortfolio]

Which is more nephrotoxic for kidney transplants: BK nephropathy or rejection?

Little data exists comparing outcomes following BK nephropathy (BKN) versus acute rejection. We reviewed outcomes among recipients who had a primary diagnosis of biopsy-proven BKN or rejection between...

Development of antibody mediated rejection shortly after acute cellular rejection in a pediatric kidney transplantation recipient.

Acute rejection is a major cause of graft loss in patients with kidney transplantations. However, the appropriate timing for performing a biopsy is often difficult to gauge in a clinical settings. We ...

Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia.

Background Single-agent ibrutinib has shown substantial activity in patients with relapsed Waldenström's macroglobulinemia, a rare form of B-cell lymphoma. We evaluated the effect of adding ibrutinib...

A Molecular Signature of Two Long Non-Coding RNAs in Peripheral Blood Predicts Acute Renal Allograft Rejection.

Acute rejection (AR) is a major complication post renal transplantation, with no widely-accepted non-invasive biomarker. This study aimed to explore the expression profiles of long non-coding RNAs (ln...

Diagnosis of Acute Cellular Rejection Using Probe-Based Confocal Laser Endomicroscopy in Lung Transplant Recipients: a Prospective, Multicenter Trial.

Acute cellular rejection (ACR) in lung transplant recipients requires demonstration of perivascular lymphocytic infiltration in alveolar tissue samples from transbronchial biopsies (TBBs). Probe-based...

Medical and Biotech [MESH] Definitions

A general term for the complex phenomena involved in allo- and xenograft rejection by a host and graft vs host reaction. Although the reactions involved in transplantation immunology are primarily thymus-dependent phenomena of cellular immunity, humoral factors also play a part in late rejection.

Non-acceptance, negative attitudes, hostility or excessive criticism of the individual which may precipitate feelings of rejection.

An immune response with both cellular and humoral components, directed against an allogeneic transplant, whose tissue antigens are not compatible with those of the recipient.

A murine-derived monoclonal antibody and ANTINEOPLASTIC AGENT that binds specifically to the CD20 ANTIGEN and is used in the treatment of LEUKEMIA; LYMPHOMA and RHEUMATOID ARTHRITIS.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

More From BioPortfolio on "Efficacy of Rituximab in Acute Cellular Rejection in Renal Transplant Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Searches Linking to this Trial