NCT03582878

Brief Summary

This is prospective randomized open single center clinical study to compare effect of sirolimus vs mycophenolate tacrolimus based protocol on pancreas and kidney graft survival in simultaneous pancreas and kidney recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2004

Completed
14.3 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

15 years

First QC Date

April 25, 2018

Last Update Submit

April 22, 2021

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Pancreas graft survival

    Number of failed pancreatic grafts, failure is defined as graft removal, death, retransplantation or return to intensified insulin regimen.

    10 years

Secondary Outcomes (3)

  • Recipient survival

    10 years

  • Wound healing time

    1year

  • Kidney graft survival

    10 years

Study Arms (2)

mycophenolate mofetil

ACTIVE COMPARATOR

mycophenolate mofetil dosing 1g before transplantation and 1g bid afterwards

Drug: Mycophenolate Mofetil

Sirolimus

EXPERIMENTAL

Sirolimus oral product Dosing 5mg orally 2-6h before transplantation Target trough levels between 5-10ng/ml

Drug: Sirolimus Oral Product

Interventions

Sirolimus Oral ProductDRUG

Oral form of sirolimus, daily dosing to achieve target trough levels between 5-10ng/ml since 1.day of transplantation

Also known as: Rapamune
Sirolimus
Mycophenolate MofetilDRUG

Mycophenolate Mofetil dosing 1g before transplantation and 1g bid afterwards

Also known as: CellCept
mycophenolate mofetil

Eligibility Criteria

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

You may qualify if:

  • Type 1 diabetes mellitus
  • End stage kidney failure
  • Negative CDC crossmatch
  • Female patients of childbearing age must have a negative pregnancy test
  • Patient must have signed the Patient Informed Consent Form.
  • Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaver transplant,

You may not qualify if:

  • Patient is pregnant or breastfeeding.
  • Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, ATG, Tacrolimus
  • Patient has malignancy or history of malignancy, with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence.
  • Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomization.
  • Patient has any form of substance abuse or psychiatric disorder or condition, which invalidate communication.
  • Severe cardiac failure or severe liver failure diagnosed at the time of transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

Related Publications (1)

  • Girman P, Lipar K, Kocik M, Voska L, Koznarova R, Marada T, Lanska V, Saudek F. Sirolimus vs mycophenolate mofetil (MMF) in primary combined pancreas and kidney transplantation. Results of a long-term prospective randomized study. Am J Transplant. 2020 Mar;20(3):779-787. doi: 10.1111/ajt.15622. Epub 2019 Oct 23.

    PMID: 31561278DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

SirolimusMycophenolic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Frantisek Saudek, MD

    Institute for Clinical and Experimental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 25, 2018

First Posted

July 11, 2018

Study Start

January 1, 2004

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)