CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

Conditions

• Kidney Pancreas Transplantation

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Envarsus XR — DRUG
  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.

Study Details

This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 20 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.

Key Dates

Start date

Feb 27, 2019

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Envarsus XR
  Envarsus XR (extended release) will be administered orally, once-daily, for 6 months.

Primary Outcome Measure

Change in patient and physician-assessed degree of tremors based on Fahn-Tolosa-Marin Tremor Rating Scale [ Time Frame: Over 6 months ]

Central Contacts

• Jon S Odorico, MD
  6082639903
  [email protected]

Locations (1)

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