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CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT03769298
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Veloxis Pharmaceuticals
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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 2 years prior, with a history of tremors following transplantation.

Condition or disease Intervention/treatment Phase
Kidney Pancreas Transplantation Drug: Envarsus XR Phase 2 Phase 3

Detailed 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 ½ 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 2 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 ½ 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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 2 years prior, with a history of tremors following transplantation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conversion From Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of Functional, Safety and Quality of Life Outcomes (CIRTEN SPK)
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor
Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Envarsus XR
Envarsus XR (extended release) will be administered orally, once-daily, for 6 months.
Drug: Envarsus XR
The Envarsus XR® drug will be administered to study participants once daily, orally. The dosage can be 0.75 mg, 1 mg or 4 mg. The tacrolimus whole blood trough concentrations will be monitored and titrate Envarsus XR® dosage to achieve target whole blood trough concentration.
Other Name: tacrolimus




Primary Outcome Measures :
  1. Change in patient and physician-assessed degree of tremors based on Fahn-Tolosa-Marin Tremor Rating Scale [ Time Frame: Over 6 months ]
    FTM-TRS will be used as a tool for essential tremor scoring. (0: no tremor, 1: barely perceptible tremor, 2: < 2 cm, 3: 2-4 cm, and 4: > 4 cm).

  2. Change in patient and physician-assessed degree of tremors based on Quality of Life in Essential Tremor (QUEST) Questionnaire [ Time Frame: Over 6 months ]
    QUEST Questionnaire, a scoring tool will be used to measure the quality of life among patients with Essential Tremor. It consists of 30 items which are rated on a five-point scale (score 0-4), corresponding to the frequency (never, rarely, sometimes, frequently, always) with which tremor was perceived to affect a function or to be associated with various feelings and attitudes. A few items (e.g. 'I had to quit my job because of tremor') could only be answered at the extremes (yes/no; true/false), and these were scored either 0 or 4.

  3. Scores on Quality of Life in Essential Tremor Questionnaires [ Time Frame: Over 6 months ]
    Use QUEST (Quality of Life in Essential Tremor Questionnaire) scoring tool

  4. Scores on Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) Questionnaire [ Time Frame: Over 6 months ]
    MTSOSD Questionnaire scores will be used to assess the presence and distress of side effects associated with the use of immunosuppressive drugs after transplantation.


Secondary Outcome Measures :
  1. Renal function by eGFR (estimated Glomerular Filtration Rate) [ Time Frame: Over 6 months ]
    Change between baseline and post-conversion as measured by eGFR

  2. Renal function by serum creatinine [ Time Frame: Over 6 months ]
    Change between baseline and post-conversion as measured by serum creatinine

  3. Comparable or improved glycemic control as measured by mixed meal tolerance test [ Time Frame: Over 6 months ]
    Change between baseline and post-conversion

  4. Comparable or improved glycemic control as measured by HbA1c [ Time Frame: Over 6 months ]
    Change between baseline and post-conversion

  5. Tacrolimus doses and levels [ Time Frame: Over 6 months ]
    Change between baseline and post-conversion

  6. Mycophenolate doses and levels [ Time Frame: Over 6 months ]
    Change between baseline and post-conversion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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- 24 months prior to screening.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769298


Contacts
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Contact: Jon S Odorico, MD 6082639903 jon@surgery.wisc.edu
Contact: Kristi Schneider, RN, MSN, ANP 6082637064 schneide@surgery.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jon S Odorico, MD    608-263-4768    jon@surgery.wisc.edu   
Contact: Kristi Schneider, APNP    6082637064    schneide@surgery.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Veloxis Pharmaceuticals
Investigators
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Principal Investigator: Jon S Odorico, MD University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:

Additional Information:
Publications:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03769298     History of Changes
Other Study ID Numbers: 2018-0821
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Wisconsin, Madison:
Tremors
Additional relevant MeSH terms:
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Pancrelipase
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents