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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 November 7, 2019

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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Descriptive Information
Brief Title  ICMJE Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
Official Title  ICMJE 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
Brief SummaryTo 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Inflammation
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Active Comparator: Arm A (CsA+Rapamune+CS)
    Intervention: Drug: CsA+Rapamune+CS
  • Experimental: Arm B (CsA+MMF+CS)
    Intervention: Drug: CsA+MMF+CS
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2013)
245
Original Actual Enrollment  ICMJE
 (submitted: May 16, 2012)
243
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion DateMarch 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01601821
Other Study ID Numbers  ICMJE 0468H-102012
B1741220
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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