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Kidney DiseasesPhase 4NCT00275535

The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

A Phase 4 study testing Anti-thymocyte globulin, Mycophenolate mofetil and Prednisone in people with Kidney Diseases, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Kidney Diseases
What is being tested?
Anti-thymocyte globulin, Mycophenolate mofetil and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteUnited States
Study dates
Apr 2001to Dec 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota

Who cannot join

  • Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant
  • Pediatric patients (<18 years of age)
  • Multi-organ transplants (e.g., kidney-pancreas, kidney-liver)
  • ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.)
  • Patients with severe hyperlipidemia (serum cholesterol >350 mg/dl or serum triglycerides >500 mg/dl
  • Patients with severe leukopenia (White Blood Cell count [WBC]<3000 10^3/ml)
  • Patients unwilling to return to the transplant center for late follow-up visits
  • Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients

This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.

Read the detailed description

The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.

Conditions
Kidney Diseases
Being tested
Anti-thymocyte globulin, Mycophenolate mofetil, Prednisone, Tacrolimus, Sirolimus
Keywords
kidney transplantation, immunosuppression, calcineurin inhibitor, sirolimus, chronic allograft nephropathy
Medical subject headings
Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-thymocyte globulinDrug

    Also called Thymoglobulin, Atgam

    Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)

  • Mycophenolate mofetilDrug

    Also called CellCept

    Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance

  • PrednisoneDrug

    Also called Deltasone, Liquid Pred, Meticorten, Orasone

    Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92

  • TacrolimusDrug

    Also called Prograf, Advagraf, Protopic

    Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)

  • SirolimusDrug

    Also called Rapamune

    Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml

Study groups in NCT00275535
Study groupRoleWhat they receive
TacrolimusActive comparatorCalcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
Receives: Drug: Anti-thymocyte globulin; Drug: Mycophenolate mofetil; Drug: Prednisone; Drug: Tacrolimus
SirolimusActive comparatorCalcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
Receives: Drug: Anti-thymocyte globulin; Drug: Mycophenolate mofetil; Drug: Prednisone; Drug: Sirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation

    Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.

    Measured: 12 months following transplantation

Secondary outcomes (5)

  1. GFR (iothalamate clearance) at other time points

    Measured: 24 months

  2. Other measures of renal function (serum creatinine, proteinuria and albuminuria)

    Measured: 24 months

  3. Acute rejection both early and after tacrolimus withdrawal

    Measured: 24 months

  4. Patient and graft survival

    Measured: 24 months after transplantation

  5. Complications-especially hypertension, diabetes, dyslipidemia

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2006 (estimated)
  2. Study startApr 2001
  3. Primary completionNov 2007
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00275535
Sponsor's protocol ID
124-01
Status last verified
Dec 2011
First submitted
10 Jan 2006
Last updated
8 Dec 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Dean PG, Grande JP, Sethi S, Park WD, Griffin MD, Cosio FG, Larson TS, Stegall MD. Kidney transplant histology after one year of continuous therapy with sirolimus compared with tacrolimus. Transplantation. 2008 Apr 27;85(8):1212-5. doi: 10.1097/TP.0b013e31816a8ae6.

    PubMed 18431244

  • Larson TS, Dean PG, Stegall MD, Griffin MD, Textor SC, Schwab TR, Gloor JM, Cosio FG, Lund WJ, Kremers WK, Nyberg SL, Ishitani MB, Prieto M, Velosa JA. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant. 2006 Mar;6(3):514-22. doi: 10.1111/j.1600-6143.2005.01177.x.

    PubMed 16468960

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anti-thymocyte globulin, Mycophenolate mofetil and Prednisone in people with Kidney Diseases, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation (time frame: 12 months following transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00275535, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.

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