NCT01062555|CompletedPhase 1/2ResultsDMC
Calcineurin Inhibitor Sparing After Kidney Transplantation
CNI-Sparing
Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation
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Sponsor study identifier
interventional
527
1 country
1
Study Start
October 1, 2006
Actual (reported)Primary Completion
April 3, 2014
Actual (reported)Study Completion
April 3, 2014
Actual (reported)Reducing drug side effects is a key issue in transplantation. One class of drugs commonly used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely, toxicity to the transplanted kidney. In some patients, this toxicity is thought to be associated with loss of transplant function in those who have had their transplants for many years. The introduction of new immunosuppression medications however, has provided the opportunity to minimize or avoid CNIs, which may reduce the occurrence of toxicity to the kidney.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 3, 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2006
Actual (reported)February 3, 2010
Actual (reported)February 4, 2010
Actual (reported)April 3, 2014
Actual (reported)April 3, 2014
Actual (reported)December 14, 2020
Actual (reported)Phase I: The Minimization of Negative Side Effects - Patient Survival
The percentage of patients alive at 6 month post transplant.
6 months
Phase II: The Minimization of Negative Side Effects - Patient Survival
The percentage of patients alive at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
up to 7 years
Phase I: The Minimization of Negative Side Effects - Graft Survival
Percent of participants at 6 months with a functioning graft (without graft failure).
6 months
Phase II: The Minimization of Negative Side Effects - Graft Survival
The percentage of patients with a functioning graft (without graft failure) at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
up to 7 years
Phase I: Acute Rejection-Free Survival
Percent of participants at 6 months without acute rejection.
6 months
Phase II: Acute Rejection-Free Survival
The percentage of patients without acute rejection at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
up to 7 years
CSA and MMF
FK and MMF
Low CNI and MMF
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Arthur Matas, MD
University of Minnesota
527 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2010
First Posted
February 4, 2010
Study Start
October 1, 2006
Actual (reported)Rapa and MMF
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 3, 2014
Actual (reported)Study Completion
April 3, 2014
Actual (reported)Last Updated
December 14, 2020
Results First Posted
December 14, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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