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Table 2 Study visits

From: Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

Visit 1 (Day −1/-3 (prestudy)) -written consent
-physical examination
-laboratory tests
-B-cell count
-assessment of allograft function
-beginning of rejection therapy (steroids) according to center standards
-randomization
Visit 2 (Day 0) -rituximab or placebo + standard concomitant medication
Visit 3 (Day 1) - physical examination
- patient history for specific side effects
Visit 4 (Day 35 ± 7) - physical examination
- laboratory tests
- B-cell count
Visit 4a: if no complete B-cell depletion (<5/μl) is achieved: second application of study medication or placebo (Visit 4a))
Visit 4b: (if study medication was administered in Visit 4a): - physical examination
- patient history for specific side effects
Visit 4c: (if study medication was administered in Visit 4a): - physical examination
- laboratory tests
- B-cell count
Visit 5 (Day 182 ± 28) - physical examination
- laboratory tests
- B-cell count
- assessment of allograft function
Visit 6 (Day 356 ± 28) - physical examination
- laboratory tests
- B-cell count
- assessment of allograft function
- re-biopsy