Kidney Allograft Dysfunction Without Reversible Causes (KADWORC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492894
Recruitment Status : Withdrawn (study terminated due to low enrollment)
First Posted : December 15, 2011
Last Update Posted : December 9, 2016
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

August 9, 2010
December 15, 2011
December 9, 2016
January 2008
October 2011   (Final data collection date for primary outcome measure)
Kidney function will be determined by the rate of change in glomerular filtration rate (GFR), estimated by serum creatinine (eGFR). [ Time Frame: Once a week for 3 month then monthly until trial ends ]
Same as current
Complete list of historical versions of study NCT01492894 on Archive Site
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Kidney Allograft Dysfunction Without Reversible Causes
A Randomized Controlled Trial of Reducing Calcineruin Inhibitor Target Level by 50% Versus Converting to Rapamycin in Chronic Kidney Dysfunction Without Reversible Causes
The purpose of this study is to learn the best way to prolong kidney life in patients exposed to calcineurin inhibitors, who already have evidence of damage possibly caused by the calcineurin inhibitor on kidney biopsy.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Graft Dysfunction
  • Drug: Cyclosporins/Tacrolimus
    Decrease the dose of calcineurin inhibitor by 1/2 and the drug level will be followed and adjusted to the target level of 50% of the previous levels
    Other Names:
    • Gengraf (cyclosporin)
    • Neoral (cyclosporin)
    • Prograf (tacrolimus)
  • Drug: Sirolimus
    Change from current calcineurin inhibitor to Sirolumus
    Other Name: Rapamune
  • Active Comparator: 50% decrease in calcineurin inhibitor
    Intervention: Drug: Cyclosporins/Tacrolimus
  • Active Comparator: Rapamune
    Intervention: Drug: Sirolimus
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Serum creatinine increased greater than or equal to 25% over baseline with no acute or reversible cause clinically evident.

    Although eGFR is arguably better for estimating kidney allograft function than serum creatinine, pragmatics dictate the use of a change in serum creatinine in the initial selection of patients. These criteria are currently used by transplant coordinators for selection of patients for the kidney biopsy as a part of large on-going study at our center.

  2. Adequate (greater than or equal to 8 glomeruli) biopsy showing Chronic allograft injury reported as mild/moderate CAN or CNI toxicity based on the previously used Banff 97 classification and no potentially reversible causes of graft dysfunction, e.g. acute rejection or treatable recurrent disease. Patients with histological evidence of mild recurrent disease that does not appear to be severe enough to explain the deterioration in function, e.g. IgA on immunofluorescence, or changes consistent with early diabetic nephropathy, will not be excluded.
  3. Receiving CsA (trough level concentration 75-125 ng/mL) or Tacrolimus(trough level concentration 6-12 ng/mL) plus MMF (or AZA) with (or without) prednisone.
  4. Able to give informed consent.

Exclusion Criteria:

  1. Urine total protein excretion >500 mg/g creatinine.
  2. eGFR (estimated by MDRD) <40 mL/min/1.73 m2
  3. Triglycerides >400 mg/dL or total cholesterol >300 mg/dL
  4. Allergy to macrolide antibiotic or rapamycin
  5. Women of child-bearing potential not using effective contraception
  6. Treated for acute rejection within the past 2 months
  7. <12 months after transplantation
  8. Potentially treatable cause(s) of allograft dysfunction, including acute rejection, dehydration, and congestive heart failure.
  9. Recurrent or de novo kidney disease that is histologically severe enough to be causing graft dysfunction
  10. Polyoma virus (BK) nephropathy, or serum positive for BK by polymerase chain reaction
  11. A second, functioning organ transplant.
  12. Receiving sirolimus.
  13. Patients with any past or present malignancy (other than non-melanoma skin cancer)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
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Principal Investigator: Aleksandra Kukula, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
December 2016

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