Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03437577
Other study ID # PHARM-2017-25529
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 8, 2018
Est. completion date March 31, 2020

Study information

Verified date March 2021
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney transplant recipients


Description:

Between four (4) months and 14 months after receiving a kidney transplant and, per standard of care (SOC), having been placed on an immediate-release (IR) tacrolimus immunosuppressant regimen, participants in this study will undergo cognitive and motor function testing and have a blood sample collected (BASELINE). Half of the participants will then be randomly converted to extended-release (XR) tacrolimus (Envarsus® XR) while the other half will remain on IR tacrolimus for the duration of the study. Both the IR and XR groups will repeat the cognitive and motor function testing and have a blood sample collected at 6, 12, and 24 weeks Post-BASELINE. A practice version of the cognitive and motor function tests will be administered no more than 60 days prior to the baseline visit (Pre-BASELINE). Alternate versions of the cognitive and motor tests will be used at each Post-BASELINE testing session to control for possible practice effects. The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney transplant recipients. The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used. Measurement of drug concentration will be the dependent variable.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Male or female kidney transplant recipient; 2. 18-65 years of age; 3. receiving a kidney transplant from a living or deceased donor; 4. if female, premenopausal and heterosexually active, must be using two forms of highly effective birth control (at least one of which must be a barrier method) which includes consistent and correct usage of established oral contraception, established intrauterine device or intrauterine system, or barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, starting at screening and throughout the study period and for 90 days after the final study drug administration; 5. written informed consent to participate in the study Exclusion Criteria: 1. younger than 18 years of age; 2. older than 65 years of age; 3. Non-native level English speaker; 4. pregnant women 5. breastfeeding women

Study Design


Related Conditions & MeSH terms

  • Kidney Transplant Failure and Rejection

Intervention

Drug:
immediate-release tacrolimus
Standard of care for transplant patients
extended release tacrolimus
Experimental care

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Controlled Oral Word Association Test (COWAT) During The Controlled Oral Word Association Test (COWAT), participants are asked to make verbal associations to different letters of the alphabet by saying all the words which they can think of beginning with a given letter. Three letters of progressively increasing associative difficulty are presented with 60 seconds allotted per letter for word retrieval. Scores are calculated as a sum of the total words produced across the 3 letter trials. The lowest possible score is zero, meaning no words could be produced. There is no limit to the higher end of the scale given that participants can produce as many words as possible for each of the three letters. Higher scores indicate greater word retrieval and better cognitive function. Outcome is reported as the change in COWAT between baseline and 6 weeks, baseline and 12 weeks, and baseline and 24 weeks. Change from baseline at 6,12, 24 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04057742 - AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation
Recruiting NCT03465397 - Individualization of the Immunological Risk Based on Selective Biomarkers in Living-donor Renal Recipients Phase 4
Not yet recruiting NCT05282966 - Assessment of QSant™ for Underlying Allograft Rejection
Recruiting NCT04388930 - The Microbiota in Kidney Donation and Transplantation
Completed NCT03611621 - A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
Recruiting NCT05397821 - Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques
Completed NCT04019353 - Cf-DNA Assay During Treatment of Acute Rejection
Active, not recruiting NCT05806749 - Immunological Tolerance in Patients With Mismatched Kidney Transplants Phase 1
Recruiting NCT04936282 - Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING) Phase 4
Enrolling by invitation NCT05285878 - Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation Phase 2
Recruiting NCT04526431 - Tacrolimus Pharmacokinetic Subpopulations
Active, not recruiting NCT03511560 - Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation Phase 4
Recruiting NCT03438773 - Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients Phase 1
Completed NCT05388955 - Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation
Completed NCT06394596 - Predicting Prognostic Factors in Kidney Transplantation Using A Machine Learning
Completed NCT04413916 - MiRNA in Kidney Transplantation: Association With Kidney Graft Function and Disease Process
Completed NCT03466775 - Anti-Angiotensin II Type 1 Receptor Antibodies and Kidney Transplant Outcomes N/A
Active, not recruiting NCT04733131 - Long-term Outcomes After Conversion to Belatacept
Active, not recruiting NCT03380962 - Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant Phase 1/Phase 2
Active, not recruiting NCT04154267 - Protocol Biopsies in High-risk Renal Transplant Recipients N/A