RituxiMab in INDuction therapy for living donor renal transplantatio

Phase 4

Completed

• Conditions: ive donor renal transplantation; Surgery

• Registration Number: ISRCTN95769119
• Lead Sponsor: Guy's and St Thomas' Hospital NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-15
• Study Completion: 2021-11-16
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

1. Adult patients aged over 18 years, either sex
2. Receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
3. Have given written informed consent

Exclusion Criteria

Amendments as of 22/12/2010:
Point 8 of the below exclusion criteria has been amended to read as follows:
8. Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant

Initial information at time of registration:
1. Previous other organ transplants lost through acute rejection
2. Patients undergoing antibody removal
3. Patients with other organ transplants
4. Patients previously treated with cylophosphamide, ATG, OKT3 or rituximab
5. Patients with white cell count below 4,500/mm^3
6. Patients with platelet count below 1,500/mm^3
7. Patients who are treated with drugs that are strong inhibitors or inducers of cytochrome P450, or treated with terfenadine, astemizole, cisapride or lovastatin
8. Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 30 days prior to transplant
9. Pregnant or breastfeeding women
10. Patients with a documented history of malignancy and its origins and treatment in the last five years. Localised basal cell carcinoma of the skin is permitted
11. Patients known to be human immunodeficiency virus (HIV), hepatitis B or C surface antigen positive
12. Patients who in the opinion of the Investigator would not be a suitable candidate for study participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate (GFR) (Modification of Diet in Renal Disease [MDRD] study calculation) at 12 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Biopsy proven acute rejection, graft and patient survival at 1 year<br> 2. Infections<br> 3. Post-transplant lymphoproliferative disorder (PTLD)<br>