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Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids

Last updated on March 14, 2019

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Study Location
Labbafinejad Hospital
Tehran, , Iran, Islamic Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13-18 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age 13 years and weight 40 kg

- End-stage renal disease, with patients receiving a primary or secondary renal
allograft from a living-unrelated donor, or from a living-related donor.

- Women who are of childbearing potential must have a negative pregnancy test before
enrollment in the study and agree to use a medically acceptable method of
contraception throughout the treatment period and for 3 months following
discontinuation from the study.

- Total white blood cell count 4.0 x 109/L (4,000/mmP3P), platelet count 100 x
10P9P/L(100,000/mmP3P), fasting triglycerides ≤ 4.6 mmol/L (400 mg/dL), fasting
cholesterol ≤ 7.8 mmol/L (300 mg/dL). If it is not possible to obtain fasting
triglycerides and cholesterol before surgery, historical values (within 1 year) may be
used.

- Signed and dated informed consent (parent or legal guardian must provide consent for
patients age enrolled in the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence of active systemic or localized major infection at the time of initial
Sirolimus administration.

- Cadaveric donors

- History of malignancy within 5 years before enrollment into the study (with the
exception of adequately treated basal cell or squamous cell carcinoma of the skin)

- Use of any investigational drug other than specified in the protocol during the 4
weeks before enrolling in the study.

- Use of planned antibody induction therapy at the time of transplantation.

- Active gastrointestinal disorder that may interfere with drug absorption.

- Known hypersensitivity to Sirolimus, MMF or Cyclosporine or its derivatives.

- Multiple organ transplants (2 or more organ transplant e.g. Kidney and Pancreas).

- Patient with high risk of rejection (eg. Patients with a PRA >50%, black patients and
patients with 2nd transplant who lost their first graft within the first 6 months).

- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
pre-study screening

NCT01601821
Pfizer
Completed
Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids

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