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Completed

NCT Number: NCT02355704

Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney

Renal Insufficiency is a priority disease in health system, which may require renal replacement therapy based on renal transplantation, which is considered as therapy of choice. During the procedure of renal transplantation, the graft could be damaged by ischemia-reperfusion which generates complications in its function.

Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

About this study

Objective: Evaluate anti-inflammatory effect of atorvastatin on renal graft in living donor transplantation.

Material and methods: Controlled, double-blind clinical trial with posterior following for 12 months. Composed by 48 patients, randomized manner, realized at the Transplant Department of Western Medical Center, Mexican Institute of Social Security. Universe was patients accepted as kidney donors. Patients were randomized in two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. Previous surgical procedure, in a blood sample, C-Reactive Protein (C-RP) and laboratory control were measured. During surgical procedure, a biopsy was obtained to measure IL-6 and tumoral necrosis factor alpha by immunohistochemistry. 24 hours after surgical procedure, 3 and 12 months of following, kidney function, complications and graft survival were registered. During surgical procedure, 3 months and 12 months of following, biopsies were obtain to performed histopathological analysis of scale of Banff

The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Accepted as kidney donor
  • Voluntary participation
  • Informed consent accepted
  • 85% fulfillment of atorvastatin treatment

Exclusion criteria

  • Hypersensibility to Atorvastatin
  • Smoking

Treatment and study plan

atorvastatin

Drug

Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure controls were performed

Other names: Lipitor

Placebo

Drug

Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure were performed

Other names: Homologated Placebo

Primary outcomes

  1. C-Reactive Protein evolution in donors

    Time frame: Basal and 4 weeks later

    C-Reactive Protein was measured when patients (donors) were accepted in the study and 4 weeks later. The last blood sample was taken the day of surgical procedure.

  2. Kidney graft rejection using scale of BANFF

    Time frame: Basal, 3 months and 12 months

    During surgical procedure and before organ transplantation, basal biopsy was obtain. In the following at 3 and 12 months after kidney transplantation, were performed the other two biopsy. Alterations between groups were registered.

Secondary outcomes

  1. Kidney function evolution after transplant

    Time frame: 24 hours, 3 months and 12 months

    In blood samples, after kidney transplantation, creatinine and urea were measured. Differences in evolution and alteration between the 2 groups were registered

  2. Interleukin and tumor necrosis factor alpha.

    Time frame: Basal

    During surgical procedure and before organ transplantation, the biopsy was obtain to measure interleukin 6 and tumor necrosis factor alpha, observing alteration between groups.

  3. Complications

    Time frame: 24 hours, 3 months and 12 months

    During surgical procedure, any kind of complication was registered, the same right after surgery and in the following.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2015
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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