CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    30
  • sponsor
    University of Wisconsin, Madison
Updated on 2 July 2021

Summary

This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30 Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no more than 5 years prior, with a history of tremors following transplantation.

Description

Accrual objective: Enrollment of 2-3 participants per month and all participants within an 18 month period. With minimum of 1 year follow-up post-conversion, we anticipate the entire study would be completed within 2 years.

Study design: This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30 Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no more than 5 years prior, with a history of tremors following transplantation.

Study duration: There will be a minimum of 1 year follow-up post-conversion, and it is expected that the entire study would be completed within 2 years.

Study aims:

  • Determine if EnvarsusXR reduces tremor severity compared to IR tacrolimus
  • Determine if EnvarsusXR improves renal function or glycemic control compared to IR tacrolimus
  • Compare the efficacy of EnvarsusXR by comparing the outcomes (patient, pancreas graft and kidney graft survival) of patients treated with Envarsus XR to those of contemporary and historical controls at our center treated with IR tacrolimus, with the goal of showing non-inferiority.
  • Compare insulin resistance and insulin sensitivity by defined measures post conversion between T1D and T2D recipients.

Primary Endpoint:

  1. Improvement in patient and physician-assessed degree of tremors based on FTM (Fahn-Tolosa-Martin Tremor Rating Scale) and QUEST (Quality of Life in Essential Tremor Questionnaire) scoring tools
  2. Scores on Quality of Life in Essential Tremor and Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) Questionnaires

Secondary Endpoints:

  1. Renal function - eGFR (estimated glomerular filtration rate) and serum creatinine
  2. Glycemic control - AUC by MMTT, fasting BG, fasting C-peptide, calculated C-peptide/glucose ratio, calculated 20/(fasting Cpeptide x fasting BG) as a measure of insulin resistance, calculated HOMA-IR (fasting insulin x fasting BG)/22.5 as a measure of insulin sensitivity/resistance, calculated BETA-2 score to sensitive estimate beta cell function, and HbA1c.
  3. Tacrolimus and Mycophenolate doses as well as TAC and MPA levels

Details
Condition Kidney Pancreas Transplantation
Treatment Envarsus XR
Clinical Study IdentifierNCT03769298
SponsorUniversity of Wisconsin, Madison
Last Modified on2 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult, 18-70 years of age
Participant must be able to understand and provide consent
History of Diabetes Type 1 or Insulin-Dependent Diabetes Type 2 with Chronic Kidney Disease (CKD)
Recipient of a Simultaneous Pancreas Kidney (SPK) transplant, 3- 60 months prior to screening, per Principal Investigator's discretion
Have a history of tremors following transplantation
Stable pancreas allograft function as evidenced by no requirement of exogenous insulin or oral anti-diabetic agents and stable pancreatic enzymes
Stable kidney allograft function
Currently taking Immediate-Release (IR) tacrolimus
Women of child-bearing potential (WOCP) must have a negative pregnancy test at the time of study entry

Exclusion Criteria

Currently maintained on an extended-release tacrolimus immunosuppressive regimen
Previous history of tremors prior to transplantation
Solitary pancreas transplant recipients
History of solid organ transplant other than a kidney or pancreas
Uncontrolled concomitant infection at the discretion of the investigator
Presence of Donor Specific Antibodies
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