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Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients

Phase 4
18 Years
75 Years
Open (Enrolling)
Disorder Related to Renal Transplantation

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Trial Information

Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients

In this triple arm, prospectively randomized multi centre phase IV study 200 patients per
study arm will be investigated for 12 months.

Based on the results of the Symphony study the low dose tacrolimus study arm will be
modified to further improve efficacy (prevention of BPAR, best possible renal function) and
safety (adverse event profile regarding infections, cardiovascular risk factors, malignant
tumours) of immunosuppression. For this, CNI will be reduced and in addition the rate of
steroid free patients after 1 week will be maximized to achieve a long lasting improved post
surgical cardiovascular risk profile (in particular concerning de novo induction of diabetes
mellitus and other adverse events caused by steroids). Safety should be increased without
loss of efficacy of immunosuppression (measured in rejection rate and allograft loss rate)
as compared to an immune suppressive therapy comprising steroids. Therefore, following the
successful study arm of the Symphony study, immunosuppression in the first of the three
study arms comprises a steroid in combination with Advagraf and CellCept in addition to a
two dose induction therapy with Simulect (group A). The regimen of the second study arm is
similar but discontinues steroids on day seven after transplantation (group B). Therapy of
group three is similar to group B but Simulect is replaced by T-cell depleting polyclonal
antibodies (Thymoglobulin) (group C).

Inclusion Criteria:

- Post mortal kidney donation or living donation

- Primary and secondary renal transplantation, unless the graft was lost due to severe
rejection within the first year

- PRA level ≤ 20%.

- Recipient ≥ 18 to 75 years of age

- AB0-compatible

- Negative crosshatch

- Patients with a signed informed consent form

- Women of child-bearing age must agree to an efficient contraception

Exclusion Criteria:

- Third or multiple transplantation

- Transplantation per a "non-heart beating" donor

- HLA-identical living donation

- Incompatibility to study medication (allergy, intolerance, hypersensitivity)

- Patients with existing malignant underlying disease or tumour anamnesis < 5 years.
Exception: basaloma or squamous cell carcinoma of the skin after successful therapy

- Female patients who do not use a safe method of contraception

- Patients with clinically significant, uncontrolled infectious diseases (incl. HIV)
and/or severe diarrhoea, emesis, active malabsorption of the upper gastrointestinal
tract or active peptic ulcer

- Patients currently, resp. within the last 30 days, participating in other studies

- Primary focal-sclerosing glomerulonephritis and membranoproliferative
glomerulonephritis as an underlying disease

- Autoimmune disease as underlying disease (collagen diseases, colitis, HUS, SLE) which
might require chronic cortisone therapy

- Additional disease requiring temporary or chronic cortisone therapy (including
inhalation medicine)

- Chronic hepatitis B and hepatitis C infection

- Thrombopenia < 70.000/mm3 or leukopenia < 2.500/mm3 or neutropenia < 1500/ mm3.

- Patients with hepatocirrhosis Child B or C or another severe disease of the liver

- Patients with symptoms of a significant somatic or psychiatric / mental illness.
Patients who are not able to realize nature, relevance and consequences of the
clinical trial and who are not able to comply, to cooperate and communicate
adequately and to follow the instructions of the study or even to give their informed
consent (according to § 40 article 4 and § 41 article 2 and 3 AMG).

- Patients who possibly depend on the sponsor or the trial physician

- Patients with signs of drug abuse or alcohol abuse

- Patients taking additional medicines with known interactions with the immune
suppressive substances (MMF and tacrolimus) that preclude an adequate control of the

- Cold ischemia time of donor kidney > 30 hours

- Pregnant or nursing patients

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Efficacy of immunosuppression measured in rejection rate confirmed by biopsy according to BANFF 97, modified 2005.

Outcome Time Frame:

one year after transplantation

Safety Issue:


Principal Investigator

Ulrich Hopt, Prof.Dr.Dr.

Investigator Role:

Study Director

Investigator Affiliation:

University Hospital Freiburg


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

June 2008

Completion Date:

September 2013

Related Keywords:

  • Disorder Related to Renal Transplantation
  • Kidney transplant status
  • Steroid free
  • Reduced
  • Calcineurin
  • Inhibitor
  • Immunosuppression