Prospective, randomized, open, 2-arm national multi-center study to evaluate the value of Rituximab in humoral chronic rejection after renal transplantation - Rituximab 2006

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006137-41-DE

Enrollment

200

Registered

2007-03-26

Start date

2007-08-07

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal transplant patients beyond 1 year post Tx, suffering from CAN and histologically proven C4d deposits and/or plasma cell and/or B-Lymphocyte (CD20+ cells) infiltration of their grafts

Interventions

Trade Name: MabThera 100mg Product Name: MabThera® Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Rituximab Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: GFR > 25 ml/min x 1,73m2 (MDRD)Time after transplantation >3 months Age >18 yearsInformed consent Biopsy proven CAN with C4d+ and/or plasma-cell and/or B-Lymphocyte (CD20+ cells) within the last 4 weeks before inclusion ACE/AT1 blocker started more than 1 week before inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hepatitis B, HIV Signs of acute cellular rejection Proteinuria >4g/24h History of malignancy within the last 5 years (except non-metastatic basal or squamous cell carcinoma of the skin) Systemic infection Leukopenia Pregnancy Participation in another investigational drug study

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the benefit of Rituximab in patients with CAN with histologically proven C4d deposits and/or plasma cell and/or B-Lymphocyte (CD20+ cells) infiltration of their grafts.;Secondary Objective: Renal function at 1 year Tolerability/ safety Graft survival at 1 and 2 years;Primary end point(s): Serum creatinine level 12 month	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026