NCT01797315

Brief Summary

Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves and relates on the other hand on the dosage. Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival. This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 4, 2017

Status Verified

February 1, 2013

Enrollment Period

4.1 years

First QC Date

February 15, 2013

Last Update Submit

May 3, 2017

Conditions

Renal Transplant Patients at High-risk for Skin Cancer

Outcome Measures

Primary Outcomes (8)

  • Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

    Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)

    at month 3

  • Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

    Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)

    at month 6

  • Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

    Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)

    at month 9

  • Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

    Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)

    at month 12

  • Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

    Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)

    at month 15

  • Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

    Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)

    at month 18

  • Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

    Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)

    at month 21

  • Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

    Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)

    at month 24

Study Arms (2)

Sirolimus

ACTIVE COMPARATOR

Patients who meet all inclusion criteria will be included into the study and randomised. If converted to Sirolimus (SRL), patients will take SRL according to the investigator's instructions and medication label, once daily preferably 4 hours after calcineurin-inhibitor medication or in case without calcineurin-inhibitor co-medication in the morning. The dose of SRL will be correlated to the former immunosuppressive therapy according to the study's conversion protocol.

Drug: Sirolimus

Standard therapy

NO INTERVENTION

Patients who will not receive SRL stay on their previous immunosuppressive therapy including one or more of the following drugs: azathioprine, cyclosporine, tacrolimus, mycophenolate-sodium and steroids.

Interventions

SirolimusDRUG
Also known as: Rapamune®
Sirolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years and older
  • minimum period of 6 month after renal transplantation
  • stable renal function and a calculated creatinine clearance of at least 40 ml/min
  • written informed consent
  • proteinuria ≤ 800 mg/d at time of enrolment
  • successfully treated solid tumor (no recurrence or metastasis in the last 2 years)

You may not qualify if:

  • Current Sirolimus- or Everolimus- intake
  • Instable graft function (creatinine clearance \< 40 ml/min)
  • Graft rejection within the 3 previous months
  • Proteinuria \> 800 mg/d
  • Non-controlled hyperlipidemia (Cholesterol \>7,8 mmol/l (300 mg/dl), Triglycerides \> 4 mmol/l (350 mg/dl)
  • Leucopenia \< 2500/nl
  • Thrombocytopenia \< 90/nl
  • Pregnancy or breastfeeding
  • Women of childbearing age without highly effective contraception
  • Known allergy to macrolides
  • Current participation in other studies
  • Refusal to sign informed consent form
  • All contraindications to SRL (see package insert, appendix)
  • Persons who are detained officially or legally to an official institute
  • Acute infections (mycotic, viral or bacterial)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 22, 2013

Study Start

March 1, 2007

Primary Completion

April 1, 2011

Study Completion

June 1, 2013

Last Updated

May 4, 2017

Record last verified: 2013-02