L-Arginine for Prevention of Kidney Damage in Liver Transplant Recipients - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587418

Purpose

Chronic renal insufficiency is a common and important health problem that causes mor-bidity and mortality among patients who have undergone liver transplantation. It is mainly caused by drugs (calcineurin inhibitors) that are used to prevent or treat rejection and once established, there is no effective treatment. This research investigates whether L-arginine can reverse the effects of calcineurin inhibitors on the kidneys and thus prevent renal insufficiency in liver transplant recipients.

Condition	Intervention
Liver Transplant Recipients	Dietary Supplement: L-arginine Dietary Supplement: Placebo

MedlinePlus related topics: Dietary Supplements Diets Liver Transplantation

Drug Information available for: Arginine Arginine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	L-Arginine Supplement for the Prevention of Calcineurin Inhibitor Nephrotoxicity

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Changes in renal plasma flow before and after arginine [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes glomerular filtration rate, cardiac output, endothelial dysfunction, plasma arginine concentration, and urinary excretion of cGMP before and after L-arginine [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Safety of oral L-arginine [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arginine: Experimental	Dietary Supplement: L-arginine Arginaid (Novartis) 1 package (9.2g) bid for 7 days
Placebo: Placebo Comparator	Dietary Supplement: Placebo Placebo powder 9.2g bid for 7 days

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed written consent
Ages 18+ at the time of entry into the study
Recipient of primary liver transplantation from a deceased or live donor
Ambulatory with satisfactory allograft function
1. Total bilirubin < 2.0 mg/dl and
2. Aminotransferase < x 3 upper limit of normal
Serum creatinine < 2mg/dl without dialysis
Maintenance immunosuppression including tacrolimus or cyclosporine
Stable hemodynamic function
1. Systolic blood pressure > 120 mmHg
2. Resting pulse rate < 100

Exclusion Criteria:

Recipient of combined liver-kidney transplantation
Prior organ transplantation (i.e., exposure to calcineurin inhibitors)
Established primary renal disease with active urinary sediments
On-going renal replacement therapy
Pulmonary hypertension (portopulmonary hypertension)
Iodine allergy
Severe diarrhea (stool output > 500g or stool frequency >5 times a day lasting more than 3 days)
Other systemic illness (e.g., infection) that require hospitalization care beyond 2 weeks after LTx

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587418

Contacts

Contact: W. Ray Kim

507.284.2511

kim.ray@mayo.edu

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

W. Ray Kim

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic ( W. Ray Kim, MD )
Study ID Numbers:	06-007047, R21-AT004174-1, AT004174
Study First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00587418 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Naphazoline
Guaifenesin
Phenylpropanolamine

ClinicalTrials.gov processed this record on May 07, 2009