Prospective Sample Collection Of Subjects For The Development Of Multiple Immunosuppressant Therapeutic Drug Monitoring Assays

Immunosuppressant Drug Monitoring Study for Transplant Patients

A
Asif Sharfuddin

Primary Investigator

Enrolling By Invitation
22 years - 100 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

The primary aim of this study is to collect biological samples that may be used in the development of future multi-drug immunosuppressant therapeutic drug monitoring assays in solid organ transplant recipients.

THIS STUDY IS ENROLLING BY INVITATION ONLY - The Investigator will collect samples from up to 3,000 adult subjects who have undergone a kidney, heart, or liver transplant and are currently prescribed Cyclosporine, Tacrolimus, Everolimus, Sirolimus, or Mycophenolic Acid (MPA) as part of their transplant care plan.

Detailed description of study

The extent of the study participation is limited to a one-time visit with venipuncture that will last no more than 60 minutes in total. which should last no morethan 60 minutes.  A blood sample (not exceed 50 mL per subject over the course of the study) will be obtained.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Liver Transplan, Heart Transplant, Kidney Transplant
  • Age: 22 years - 100 years
  • Gender: All

Inclusion Criteria
1. Subject is older than or equal to 22 years of age
2. Subject has received a liver, heart, or kidney transplant and is currently prescribed
Tacrolimus, Cyclosporine, Sirolimus, Everolimus, or Mycophenolic Acid (MPA)
specifically as part of the immunosuppressive regimen for the transplanted organ
3. Subject is donating blood at either the peak OR trough time as defined for each drug
4. Subject is willing to provide written informed consent, which includes future use
Exclusion Criteria
1. The subject has previously donated blood for this study for the same drug, irrespective
of organ.

This study investigates the collection of biological samples from individuals who have received a kidney, heart, or liver transplant. The purpose is to develop assays for monitoring immunosuppressant drugs. Immunosuppressant drugs are medicines that lower the body’s immune system response, which is important for transplant patients to prevent organ rejection.

Participants will have a one-time visit where a blood sample will be taken. This process will involve a venipuncture, which is a procedure to draw blood using a needle. The visit will last no more than 60 minutes, and no more than 50 mL of blood will be collected.

  • Who can participate: Adults aged 22 and older who have had a liver, heart, or kidney transplant and are currently prescribed specific immunosuppressant drugs can participate. Participants must not have previously donated blood for this study for the same drug.
  • Study details: The blood sample will be used to develop future drug monitoring tests.
  • Study visits: The study requires 1 visit.
Updated on 15 Jun 2026. Study ID: NEPH-RDI-RCD-2818, 31006
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only