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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01492894
Other study ID # 0708M13942
Secondary ID
Status Withdrawn
Phase Phase 4
First received August 9, 2010
Last updated December 8, 2016
Start date January 2008
Est. completion date October 2011

Study information

Verified date December 2016
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
Sirolimus
Change from current calcineurin inhibitor to Sirolumus

Locations

Country Name City State
United States University of Minnesota Departments of Medicine and Surgery Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kidney function will be determined by the rate of change in glomerular filtration rate (GFR), estimated by serum creatinine (eGFR). Once a week for 3 month then monthly until trial ends Yes
See also
  Status Clinical Trial Phase
Completed NCT03155763 - Histology of Implantation Biopsies and Kidney Allograft Outcomes N/A