For more information and to see if you may qualify
for these studies,
please contact the Transplant Clinical Research office at: (608)
263-2565
Study #1
Title: Randomized Steroid withdrawal in kidney
transplant recipients (ROTRF SW) PI: Hans Sollinger, MD
Eligibility Criteria
Male and female kidney transplant recipients ages 55 and older
Must be at least 1 year after the kidney transplant surgery
Must be taking MMF (CellCept) therapy for the past 6 months
No history of a kidney rejection episode in the past year and
no more than one rejection episode of the kidney since the transplant
No medical condition requiring daily prednisone dosing
Must be taking either cyclosporine or tacrolimus
Study Summary
Participation in this study is completely voluntary. If you
are eligible and agree to participate, one of your immunosuppressive
medications (prednisolone, commonly referred to as steroids) will
be reduced and eventually discontinued over the course of 3 months.
In addition, you will also be asked to consent to a separate study
where blood will be drawn and used in a new test to look for how
your immune cells are responding to withdrawal of immuno-suppression
and to your transplant. We will enroll 75 patients in this study
from the University of Wisconsin, and steroids will be withdrawn
in 50 of those patients, while the remaining patients will continue
on their current medications.
During the steroid withdrawal period (3 months), you will be
required to have blood drawn every other week to check for rejection
(if you are assigned to gradually stop taking prednisone). If
you experience a rejection episode, steroids will be started again.
Study #2
Title: Folic Acid for Vascular Outcome Reduction
in Transplantation, PI: John Pirsch, MD
Eligibility Criteria
Male and female kidney or combined kidney and pancreas transplant
patients 35-75 years of age
Must be at least 6 months after the transplant surgery
Have stable kidney function at the time of screening (creatinine
clearance of at least 25 ml/minute for females and 30 ml/minutes
for males
Study Summary
This research study is being done to compare the effectiveness
of taking a daily multivitamin with a high dose combination of
folic acid, vitamin B12 and vitamin B6 versus a standard multivitamin
without folic acid and Estimated Average Requirement (EAR) amounts
of vitamins B6 and B12, in order to decrease the occurrence of
heart disease and related complications such as strokes, heart
attacks, chest pain and poor circulation in the legs, in kidney,
kidney-pancreas or kidney-bone marrow transplant patients.
This research study is being conducted in a “blinded”
manner, which means that neither you nor your doctor will know
whether you are receiving the standard multivitamin, or the study
multivitamin with the high dose combination of folic acid, vitamin
B6 and B12. In order for the study to be blinded, both types of
multivitamins will look identical. Half of the study participants
will be assigned to receive the standard multivitamin and the
other half of the study participants will be assigned to receive
the study multivitamin with the high dose combination of folic
acid, vitamin B6 and B12.
If you decide to participate in this research study, you will
have a screening study visit to determine your study eligibility.
If you are eligible for study participation, you will return between
3 weeks and 120 days after the screening visit for a randomization
study clinic visit. At that visit you will be randomized into
the study and you will start taking your assigned study multivitamin.
After the randomization study visit, you will have a study clinic
visit each year, for a total of 5 years (Years 1, 2, 3, 4 and
5). At each study visit, your medical history will be reviewed,
you will have a physical exam and research blood and urine samples
will be obtained. You will also have brief telephone visits, at
months 6, 18, 30, 42 and 54, to review your medical history, to
check the amount of study vitamins that you have, and to review
any vitamin side effects that you may be experiencing.
Study #3
Title: A study to see if kidney transplant patients
who have received Campath-1H, are able to take one less anti-rejection
medication each day, to prevent kidney rejection. (ILEX CI Withdrawal),
PI: Stuart Knechtle, MD
Eligibility Criteria
Are between 18 and 75 years of age
Received Campath-1H medication at the time of your transplant
surgery
Received a kidney transplant at least 2 months ago and have not
recently had a rejection episode of the kidney
You are currently taking prednisone, CellCept (MMF), and either
cyclosporine or tacrolimus
Study Summary
The University of Wisconsin Transplant Department is conducting
a research study to see if kidney transplant recipients who received
a new type of anti-rejection medication called Campath-1H, can
take one fewer anti-rejection medication each day (either cyclosporine
or tacrolimus), and improve their kidney function. In addition,
we hope to learn more about how Campath-1H can prevent rejection
of kidney transplants. This study may help us to understand whether
individual responses to treatment with Campath-1H (in combination
with either cyclosporine or tacrolimus), are related to any particular
proteins found in the blood or kidney tissue of kidney transplant
recipients. These treatment results will be compared to the results
in kidney transplant subjects treated with Campath-1H who are
assigned to stop taking either cyclosporine or tacrolimus.
If you choose to participate in the study, and you are eligible,
you will then be randomly assigned by chance (like the flip of
a coin) to stop taking either cyclosporine or tacrolimus anti-rejection
medication, or to continue taking this type of medication every
day to prevent rejection. One half of the subjects who participate
in the study will be assigned to continue taking their cyclosporine
or tacrolimus medication (Group 1) and the other half of the subjects
in this study will be assigned to stop taking their cyclosporine
or tacrolimus medication (Group 2).
You will have a study visit (Day 1) on the day that you enroll
in the study and at Months 1, 3, 6, 12, 24, and 36 after starting
the study. Subjects in treatment Group 2 will also have an extra
study visits at Month 2 to evaluate the function of the transplanted
kidney. Subjects in treatment Group 2 will have their total daily
dose of cyclosporine or tacrolimus reduced by 50% on Day 1 of
the study, and then gradually reduced over the next few months,
so that by Month 3 of the study, the dosing will be stopped completely.
Blood and urine tests will be obtained at every study visit to
monitor your health and the health of your kidney. You will also
have a biopsy of your transplanted kidney at your Months 12 and
24 study visits, in order to check the health of your transplanted
kidney.
Study #4
Title: A study that evaluates switching kidney
and liver transplant recipients with tacrolimus-associated abnormal
glucose metabolism to Neoral® with C2 monitoring, PI:
John Pirsch, MD
Eligibility Criteria
Male and female liver or kidney transplant recipients who are
ages 18-70
Kidney transplant recipients must be at least 2 weeks after and
no more than 3 years after their transplant
Liver transplant recipients must be at least 8 weeks after and
no more than 3 years after their transplant
Subjects must be taking tacrolimus (Prograf)
Subjects must have stable transplanted organ function
Study Summary
This research study is being done to see if a change in one of
the anti-rejection medications, from tacrolimus to Neoral®
(cyclosporine), will improve blood sugar levels and/or reduce
the need for blood sugar control medications, in kidney and liver
transplant patients with new blood sugar problems. Tacrolimus
and Neoral® are both approved by the Food and Drug Administration
(FDA) to prevent rejection of transplanted organs.
If you choose to participate in this study, you will have a baseline
study visit to determine if you are eligible to be in the study.
If you are eligible and decide to be in the study, you will then
be assigned to continue taking tacrolimus or begin taking Neoral®.
By random selection (by chance) two out of every three people
who participate in this study will be converted from tacrolimus
therapy to Neoral®, and the remaining study subjects will
continue to take tacrolimus therapy to prevent rejection of their
transplanted organ. You will have 5-7 additional study visits
during the next 26 weeks after starting the study. At each study
visit, you will have study blood tests and physical examinations
performed, to make sure that you are doing well. You will also
be asked about any health problems you have noticed since your
last study visit and any medications you have taken to treat your
blood sugars.
Study #5
Title: A Phase 1 study to evaluate the safety
of a new anti-rejection medication called CP-690,550 in stable
kidney transplant recipients, PI: John Pirsch, MD
Eligibility Criteria
Male and female transplant patients ages 18-70
Subjects must be at least 6 months after the kidney transplant
surgery
Subjects must have a stable blood creatinine level of less than
2.5
No rejection episodes in the past 3 months
No history of CMV (Cytomegalovirus) disease
No history of Hepatitis B or Hepatitis C
No history of cancer (other than skin cancer)
Study Summary
This research study is being done to evaluate the safety, tolerability,
pharmacokinetics (how a drug moves through your body), and pharmacodynamics
(how much of the drug is in your body and for how long) of CP-690,550
when given with mycophenolate mofetil (MMF) for the prevention
of rejection in kidney transplant patients. CP-690,550 is an investigational
new drug, which means that it is not approved by the Food and
Drug Administration (FDA), and is only available in research studies.
Four dosing groups of CP-690,550 are planned in this study. Eight
subjects will be assigned to each of the first 3 dosing group.
Two subjects in each of the first 3 dosing groups will be randomly
assigned (by chance) to receive a placebo (sugar pill) and six
subjects will receive the active study drug CP-690,550. In the
fourth dosing group four subjects will receive placebo, and 24
subjects will receive the active study drug CP-690,550. All study
participants will take MMF with or without prednisone in this
study, to prevent organ rejection.
If you decide to participate in this study, you will have a screening
visit to determine if you are able to be in the study. If you
are found to be eligible you will then have 10 additional study
visits during the next 57 days. Two of the study visits will be
conducted over the phone. The study visit on Day 1 will take about
13 hours to complete. The study visit on Day 29 will require an
overnight stay a hotel in the Madison area and will take about
25-26 hours to complete. You will have blood tests drawn at most
study visits. These blood samples will check your health and kidney
function, measure the amount of the CP-690,550 study drug in your
blood and to look for certain viral infections in your blood.
You will also have several physical examinations, EKG’s,
bladder x-rays and your vital signs will be measured at each visit.
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