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Kidney Allograft Dysfunction Without Reversible Causes

NCT ID: NCT01492894

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Graft Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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50% decrease in calcineurin inhibitor

Group Type ACTIVE_COMPARATOR

Cyclosporins/Tacrolimus

Intervention Type DRUG

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

Rapamune

Group Type ACTIVE_COMPARATOR

Sirolimus

Intervention Type DRUG

Change from current calcineurin inhibitor to Sirolumus

Interventions

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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

Intervention Type DRUG

Sirolimus

Change from current calcineurin inhibitor to Sirolumus

Intervention Type DRUG

Other Intervention Names

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Gengraf (cyclosporin) Neoral (cyclosporin) Prograf (tacrolimus) Rapamune

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aleksandra Kukula, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota Departments of Medicine and Surgery

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0708M13942

Identifier Type: -

Identifier Source: org_study_id