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Table 1 Main inclusion and Exclusion criteria

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

Inclusion criteria 1. Kidney transplantation >6 weeks and <12 months before randomization
2. Age ≥18 years
3. Presence of an acute T-cell mediated tubulointerstitial rejection (Banff IA or IB) or Banff borderline rejection with simultaneous serum creatinine increase of ≥20% over baseline
4. Significant numbers of B-cell infiltrates (defined as >30 CD20+cells /hpf)
5. Absence of C4d and SV40
6. Creatinine clearance >25 ml/min.
7. Reliable contraception
8. Written informed consent
Exclusion criteria 1. Known adverse reactions against rituximab or concomitant medication
2. Application of rituximab for any reason 12 months prior inclusion
3. Women who are pregnant or breastfeeding
4. Active CMV, HIV, replicative Hepatitis B or C, or other relevant infections
5. Splenectomy
6. Heart insufficiency (NYHA III-IV)
7. Severe arrhythmia
8. Insufficiently controlled diabetes mellitus (HbA1c >10 %)
9. Contraindication for a second transplant biopsy (for example, coagulation disorders)
10. Other reasons according to the assessments of the study physician