Condition category
Surgery
Date applied
20/06/2005
Date assigned
04/10/2005
Last edited
24/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Markus Guba

ORCID ID

Contact details

Dept of Surgery
Hospital of the University of Munich (LMU)
Klinikum Grosshadern
Marchioninistr. 15
Munich
81377
Germany
+49 89 7095 3573
markus.guba@med.uni-muenchen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00/03 - A2, V 12.04.2005

Study information

Scientific title

Acronym

SMART

Study hypothesis

Early conversion to a calcineurin-inhibitor-free protocol with Sirolimus (Rapamune®) in combination with MMF (Cellcept®) and corticosteroids is superior to a standard protocol with Cyclosporin (Sandimmun®) in combination with MMF (Cellcept®) and corticosteroids at the level of graft-function at 12 months.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Terminal renal failure

Intervention

Patients with terminal renal failure undergoing renal transplantation.

After an initial immunosuppression with Cyclosporin, MMF and Steroids for 10-24 days, patients in the study group A are converted to Sirolimus, MMF and Steroids. Patients in the control group continue on Cyclosporin, MMF and Steroids.

Intervention type

Drug

Phase

Not Specified

Drug names

Serolimus (Rapamune®), MMF (Cellsept®), cyclosporin (Sandimmun®), corticosteroids

Primary outcome measures

Graft function at 12 months defined as creatinine clearance calculated according to the Cockroft-Gault formula and serum creatinine level.

Secondary outcome measures

1. Incidence of biopsy proven acute rejection episodes according to Banff 97 classification
2. Patient and graft survival at 12 months
3. Incidence of treatment failure defined as:
a. Switch to another immunosuppressive regimen
b. Continuing removal of a single immunosuppressant (except MP)
c. Switch to another immunosuppressive regimen because of side effects
4. Incidence of infections
5. Incidence of malignancies
6. Incidence of new onset of hypertension
7. Incidence of side effects (e.g. metabolic disorders, others)

Overall trial start date

01/03/2005

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female patients between 18 and 60 years of age
2. Primary or secondary kidney allograft recipients (PRA <30%)
3. No requirement for dialysis since three days before randomization
4. Women of childbearing potential must have a negative qualitative pregnancy test before Sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for three months following discontinuation of Sirolimus. Any woman becoming pregnant during the treatment period must discontinue Sirolimus treatment
5. Signed and dated informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. Multiorgan transplant recipients
2. Cold ischemia time >36 hours
3. PRA > 30%
4. Postoperative technical complications necessitating re operation (e.g. kidney artery stenosis) or wound healing disturbances (e.g. voluminous lymphoceles)
5. Recipients of A-B-0 incompatible grafts
6. Body mass index >32
7. Patients with cardiac infarction within six months before study entry or actual unstable coronary heart disease
8. Total number of neutrophile granulocytes <1,500/mm^3 or leucocytes <2,500/mm^3 at screening
9. Patients with severe hepatic impairment (glutamic-oxaloacetic transaminase
[GOT], glutamic-pyruvic transaminase [GPT], total bilirubin above three times the norm)
10. Total cholesterol >300 mg/dl and triglycerides >400 mg/dl (even under lipid lowering treatment)
11. Patients with severe intestinal disorders or other diseases significantly influencing resorption, distribution, metabolism and elimination of study medication (except diabetes) at the discretion of the investigator
12. Recipients positive for hepatitis B surface antigens or human immunodeficiency virus (HIV), organs from donors positive for hepatitis B surface antigens or HIV
13. Active malignancies within two years before study entry with the exception of squamous cell carcinoma and basal cell carcinoma of the skin
14. Patients with active systemic infections or significant coagulopathy or requirement of long term anticoagulation therapy after transplantation
15. Use of any investigational drug within four weeks before study entry
16. Known intolerability of Cyclosporine, Sirolimus, MMF or other medication required after transplantation
17. Patients with diseases which potentially could impair study performance at the discretion of the investigator
18. Pregnancy and lactation
19. Refusal to sign informed consent form
20. Patients with ongoing requirement of dialysis at time of randomization

Recruitment start date

01/03/2005

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Dept of Surgery
Munich
81377
Germany

Sponsor information

Organisation

University of Munich - Department of Surgery (Germany)

Sponsor details

Department of Surgery
Hospital of the University of Munich (LMU)
Klinikum Grosshadern
Marchioninistrasse 15
Munich
81377
Germany
+49 89 7095 2790
ml-kks-chirurgie@med.uni-muenchen.de

Sponsor type

University/education

Website

http://www.surgery-grosshadern.de/

Funders

Funder type

Industry

Funder name

Wyeth Pharmaceuticals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes