Atorvastatin in the Recipient's Kidney Graft From a Living Donor

NCT02522117 | Completed Phase 3 DMC

• 1 other identifier: R-2013-1301-100
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Renal insufficiency is a priority disease in the health system, which may require renal replacement therapy based on kidney transplantation, which is considered as therapy of choice. During the procedure of kidney transplantation, the body is subjected to ischemia-reperfusion damage that generates late complications related to graft function. Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in kidney transplantation.

Conditions

Renal Insufficiency

Keywords

Kidney Transplantation; Atorvastatin; Human Leukocyte Antigens; Interleukin

Outcome Measures

Primary Outcomes (1)

• HLA levels in the kidney graft biopsy

  HLA levels were measure by immunohistochemistry, observing alteration between groups.

  12 months

Secondary Outcomes (5)

• Renal function

  12 months

• Kidney graft survival

  12 months

• Surgery complications

  12 months

• TNFalpha levels in the kidney graft biopsy

  12 months

• IL2 and IL6 levels in the kidney graft biopsy

  12 months

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

24 patients received oral atorvastatin 40 mg once a day, for 4 weeks.

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

24 patients received oral placebo 40 mg once a day, for 4 weeks.

Drug: Placebo

Interventions

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 transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient's kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.

Also known as: Lipitor

Atorvastatin

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 transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient's kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.

Also known as: Homologated placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accepted as kidney donor
• Voluntary participation
• Informed consent accepted
• % fulfillment of atorvastatin treatment
• Entitlement to the Mexican Institute of Social Security

You may not qualify if:

• Hypersensibility to Atorvastatin
• Smoking
• Accepted as kidney recipient
• Entitlement to the Mexican Institute of Social Security
• Patients who dropped out from study or withdrew the informed consent
• Insufficient kidney biopsy

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Clotilde Fuentes-Orozco, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

ME (1)