Kidney Allograft Dysfunction Without Reversible Causes (KADWORC)

This study has been terminated.
(study terminated due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01492894
First received: August 9, 2010
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Kidney Graft Dysfunction
Drug: Cyclosporins/Tacrolimus
Drug: Sirolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Reducing Calcineruin Inhibitor Target Level by 50% Versus Converting to Rapamycin in Chronic Kidney Dysfunction Without Reversible Causes

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: January 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 50% decrease in calcineurin inhibitor 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)
Active Comparator: Rapamune Drug: Sirolimus
Change from current calcineurin inhibitor to Sirolumus
Other Name: Rapamune

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492894

Locations
United States, Minnesota
University of Minnesota Departments of Medicine and Surgery
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Aleksandra Kukula, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01492894     History of Changes
Other Study ID Numbers: 0708M13942
Study First Received: August 9, 2010
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Sirolimus
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 28, 2014