Tacrolimus to Sirolimus Conversion for Delayed Graft Function

NCT00931255

Last updated date
Study Location
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplant, Delayed Graft Function
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Age => 18.

2. Recipient of a deceased donor kidney transplant.

3. Delayed graft function, defined as need for dialysis during first week after surgery or slow graft function, defined as creatinine >=3.0 by post-op day 5 without requiring dialysis

4. Stable serum creatinine for 2 weeks prior to enrollment.

5. Able to give informed consent.

6. Compliant with medical regimen and clinic visits.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Episode of acute rejection within 4 weeks prior to enrollment.


2. Calculated GFR < 30 ml/min.


3. Interstitial fibrosis & tubular atrophy in transplant biopsy higher than grade II
(Banff"05 update).


4. Proteinuria > 500 mg/24 h or spot urine protein/creatinine > 0.5.


5. Total fasting cholesterol level > 300 mg/dl or triglyceride > 500 mg/dl despite
optimal lipid lowering therapy.


6. Recipient of pancreas or liver allografts.


7. Leukopenia (WBC < 3000 mm3) within 2 weeks prior to enrollment.


8. Leukopenia (WBC < 2000 mm3) within 4 weeks prior to enrollment.


9. Thrombocytopenia (platelets count < 100,000/mm3) within 2 weeks prior to enrollment.


10. Unwilling to comply with study protocol.


11. Enrollment in another drug trial that precludes use of sirolimus.


12. Diagnosis of malignancy within 2 years prior to enrollment, except adequately treated
non-melanoma skin cancer.


13. For women, pregnancy.


14. Allergy to iodine

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Kidney Transplant, Delayed Graft FunctionTacrolimus to Sirolimus Conversion for Delayed Graft Function
NCT00931255
  1. Baltimore, Maryland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Tacrolimus to Sirolimus Conversion for Delayed Graft Function
Official Title  ICMJE Delayed Tacrolimus to Sirolimus Conversion in Renal Transplant Recipients With Delayed Graft Function
Brief Summary The objective of this study is to evaluate the safety and efficacy of conversion from tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft function (DGF)and slow graft function (SGF) in improving graft function and delaying chronic allograft nephropathy. The investigators hypothesize that conversion from tacrolimus to sirolimus in renal transplant recipients with DGF/SGF in early months after surgery will improve graft function and decrease the progression of graft fibrosis.
Detailed Description

Eligible study subjects will be randomized into two groups 8-18 weeks after surgery. One group will be maintained on tacrolimus according to the standard of care at our center. In the second group tacrolimus will be converted to sirolimus, with one week overlap between sirolimus therapy and tacrolimus taper. All the deceased donor kidney transplant recipients transplanted at our center who experience DGF/SGF are eligible for inclusion in this study, if they meet the inclusion/exclusion criteria as detailed later.

Data will be collected on patient demographics, duration on dialysis, history of diabetes and chronic hepatitis C, previous transplantation, PRA, donor source, warm and cold ischemia time, donor demographics and comorbidity such as diabetes and hypertension, serum creatinine at the time of organ removal, early graft function, number of dialysis treatments after transplantation, induction agent and immunosuppressive regimen including the dose or level of the drugs at 3, 6, 9, 12, 18, and 24 months. Similar data regarding use of ACE inhibitors/ARBs, erythropoietic agents, number of anti-hypertensives and lipid lowering agents will be collected. In addition, the following tests and procedures will be obtained for this study.

  1. GFR measurement by cold iothalamate method at one year after transplantation.
  2. Evaluation of routine surveillance graft biopsies for chronic changes at 3 and 12 months posttransplant by morphometric analysis.
  3. Spot urine protein, albumin, and creatinine measurement at 3 and 12 months.
  4. Estimate GFR at 3, and 12 months using MDRD, CG, and Nankivell formulas
  5. Examine the surveillance and indicated biopsies for acute rejection and BK nephropathy.
  6. Fasting lipid profile at 3 and 12 months for all patients, and 24 months for those with at least 2 years of follow up.
  7. Office blood pressure measurements at 3 and 12 months for all patients, and 24 months for those with at least 2 years of follow up.
  8. Measurement of CRP, IL-6, and MCP at 3 and 12 months.

The safety measures will include:

Incidence of leukopenia (WBC < 3000) or thrombocytopenia (PLT < 100,000); hemoglobin level at 12 months; proteinuria at 12 months; incidence of oral aphthous ulcers; incidence of new onset diabetes, incidence of CMV infection and rate of drug withdrawal due to side effects.

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
  • Kidney Transplant
  • Delayed Graft Function
Intervention  ICMJE
  • Drug: Tacrolimus
    3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol
    Other Name: FK506, Prograf
  • Drug: Sirolimus
    5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
    Other Name: Rapamune, Rapamycin
Study Arms  ICMJE
  • Active Comparator: Tacrolimus
    Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.
    Intervention: Drug: Tacrolimus
  • Active Comparator: Sirolimus
    5 mg, PO , daily
    Intervention: Drug: Sirolimus
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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 13, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2009)
80
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age => 18.
  2. Recipient of a deceased donor kidney transplant.
  3. Delayed graft function, defined as need for dialysis during first week after surgery or slow graft function, defined as creatinine >=3.0 by post-op day 5 without requiring dialysis
  4. Stable serum creatinine for 2 weeks prior to enrollment.
  5. Able to give informed consent.
  6. Compliant with medical regimen and clinic visits.

Exclusion Criteria:

  1. Episode of acute rejection within 4 weeks prior to enrollment.
  2. Calculated GFR < 30 ml/min.
  3. Interstitial fibrosis & tubular atrophy in transplant biopsy higher than grade II (Banff"05 update).
  4. Proteinuria > 500 mg/24 h or spot urine protein/creatinine > 0.5.
  5. Total fasting cholesterol level > 300 mg/dl or triglyceride > 500 mg/dl despite optimal lipid lowering therapy.
  6. Recipient of pancreas or liver allografts.
  7. Leukopenia (WBC < 3000 mm3) within 2 weeks prior to enrollment.
  8. Leukopenia (WBC < 2000 mm3) within 4 weeks prior to enrollment.
  9. Thrombocytopenia (platelets count < 100,000/mm3) within 2 weeks prior to enrollment.
  10. Unwilling to comply with study protocol.
  11. Enrollment in another drug trial that precludes use of sirolimus.
  12. Diagnosis of malignancy within 2 years prior to enrollment, except adequately treated non-melanoma skin cancer.
  13. For women, pregnancy.
  14. Allergy to iodine
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00931255
Other Study ID Numbers  ICMJE HP-00042201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abdoleza Haririan, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Abdolreza Haririan, MD, MPHUniversity of Maryland, College Park
PRS Account University of Maryland, Baltimore
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP