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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 December 16, 2017

FOR MORE INFORMATION
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.
Show details

- 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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Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
An Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids With Further CSA Elimination In The Rapamune Arm With The Introduction Of MMF
To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Inflammation
  • Drug: CsA+Rapamune+CS
    Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months
  • Drug: CsA+MMF+CS

    The control arm is the standard local practice (official protocol) in Iran:

    Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS.

  • Active Comparator: Arm A (CsA+Rapamune+CS)
    Intervention: Drug: CsA+Rapamune+CS
  • Experimental: Arm B (CsA+MMF+CS)
    Intervention: Drug: CsA+MMF+CS
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 <18 years of age). An assent form will be signed by patients < 18 years of age enrolled in the study.

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
13 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01601821
0468H-102012
B1741220
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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