Kidney Allograft Dysfunction Without Reversible Causes (KADWORC)
This study has been terminated.
(study terminated due to low enrollment)
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
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
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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:
|
| 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:
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.
- 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.
- 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.
- Able to give informed consent.
Exclusion Criteria:
- Urine total protein excretion >500 mg/g creatinine.
- eGFR (estimated by MDRD) <40 mL/min/1.73 m2
- Triglycerides >400 mg/dL or total cholesterol >300 mg/dL
- Allergy to macrolide antibiotic or rapamycin
- Women of child-bearing potential not using effective contraception
- Treated for acute rejection within the past 2 months
- <12 months after transplantation
- Potentially treatable cause(s) of allograft dysfunction, including acute rejection, dehydration, and congestive heart failure.
- Recurrent or de novo kidney disease that is histologically severe enough to be causing graft dysfunction
- Polyoma virus (BK) nephropathy, or serum positive for BK by polymerase chain reaction
- A second, functioning organ transplant.
- Receiving sirolimus.
- Patients with any past or present malignancy (other than non-melanoma skin cancer)
Contacts and Locations
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 May 16, 2013