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2024-517391-38-00RecruitingPhase 4

SIROLIMUS VERSUS MYCOPHENOLATE MOFETIL IN SIMULTANEOUS PANCREAS AND KIDNEY TRANSPLANTATION TO EVALUATE THE RISK OF HERNIA

Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

To compare the incidence of incisional hernia following combined pancreas and kidney transplantation in type 1 diabetic subjects with end-stage kidney disease treated with to different immunosuppressive rengimens

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
120 (estimated)
First submitted
10 Sept 2024
Start date
9 Sept 2020
Lead sponsor
Institute For Clinical And Experimental Medicine
EU CT number
2024-517391-38-00
EudraCT number
2019-002240-24

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 120
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient receives a kidney transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone

Other illness

  • Patient has a history of an extensive abdominal operation or a hernia in the abdominal wall
  • Patient is allergic or intolerant to any drug comprising both immunosuppressive protocols
  • Patient has malignancy or history of malignancy, with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence.
  • Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication

Lab values

  • Patient has a positive T-cell cross-match on the most recent serum specimen
  • Patient is known for active liver disease or has significant liver disease; defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal

Age

  • Donor is older than 65 years of age

Other

  • Patient is pregnant or breastfeeding
  • Patient has a high immunological risk, defined as a PRA grade > 50%

Who the study is looking for

  • 1 Male or female patients, of 18 to 65 years of age, with a pre- or an end-stage renal failure, Type 1-diabetic nephropathy
  • Patient is scheduled to be put on waiting-list for a primary simultaneous pancreas/kidney (SPK) cadaver transplant

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Institute for Clinical and Experimental MedicinePragueCzechiaRecruiting

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