An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens

NCT01183247 | Completed Phase 4

• 1 other identifier: 187/07
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

An open, single center, randomised study to investigate three different immunosuppressive regimens for de novo renal transplant recipients:

1. 1.st sirolimus / EC-MPS / tacrolimus regimen
2. 2.nd everolimus / EC-MPS / tacrolimus regimen
3. 3.rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is performed. If no rejection is detected prednisone is withdrawn.

Conditions

Comparative Study; Immunosuppressive Agents

Keywords

Everolimus,; rapamycin,; prednisone,; tacrolimus,; MMF,; steroid-free,; protocol biopsy

Outcome Measures

Primary Outcomes (1)

• Plasma creatinine and creatinine clearance (Cockcroft-Gault) after 6 months of treatment

  6 months

Study Arms (3)

Rapamycin

ACTIVE COMPARATOR

Rapamycin-MMF-tacrolimus

Drug: Rapamycin

Everolimus

ACTIVE COMPARATOR

Everolimus - tacrolimus - MMF

Drug: Everolimus

Prednisone

ACTIVE COMPARATOR

tacrolimus - MMF -prednisone

Drug: Prednisone

Interventions

Rapamycin DRUG

Add rapamycin de novo to tacrolimus and MMF

Also known as: Sirolimus

Rapamycin

Everolimus DRUG

Add everolimus de novo to tacrolimus and MMF

Everolimus

Prednisone DRUG

Add prednisone de novo to tacrolimus and MMF

Prednisone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between 18 and 75 years of age, regardless of race.
• Female patients of child bearing age agree to maintain effective birth control practice during the study.
• Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation as assessed by the transplantation centre.
• Patient has been fully informed and has given written or independent person witnessed oral informed consent.

You may not qualify if:

• in Patient is pregnant or breastfeeding.
• Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
• Patient has a high immunological risk constellation, defined as having donor specific HLA-antibodies and/or having a previous graft survival shorter than 3 years due to rejection.
• Patient and donor have a positive T or B-cell crossmatch.
• Patient and donor are ABO incompatible.
• Age of donor \> 75 years.
• Cold ischemia time \> 36 hours.
• Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
• Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
• Patient is allergic or intolerant to cremophor RH 60 or structurally related compounds, steroids, everolimus, tacrolimus, Sirolimus or EC-MPS.
• Patient or donor is known to be HIV positive.
• Patient has significant liver disease, defined as having during the past 28 days continuously ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 fold of the upper value of the normal range of the investigational site.
• Patient with malignancy or history of malignancy ≤ 2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
• Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
• Patient is taking or has been taking an investigational drug in the past 28 days.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Novartis: collaborator

Study Sites (1)

Clinic for transplantation immunology and nephrology

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Sirolimus; Everolimus; Prednisone

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Juerg U Steiger, Professor

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 17, 2010
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 17, 2010

Record last verified: 2010-08

Locations

CH (1)