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L-arginine for Prevention of Kidney Damage in Liver Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
W. Ray Kim, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587418
First received: December 21, 2007
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

Chronic renal insufficiency is a common and important health problem that causes morbidity 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: L-arginine Supplement for the Prevention of Calcineurin Inhibitor Nephrotoxicity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Changes in eGFR before and after L-arginine [ Time Frame: 7 days with option for 12 week maintenance phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary excretion of cGMP before and after L-arginine. Creatinine before and after L-arginine. [ Time Frame: 7 days with option for 12 week maintenance phase ] [ Designated as safety issue: No ]
  • Safety of oral L-arginine [ Time Frame: 7 days with option for 12 week maintenance phase ] [ Designated as safety issue: Yes ]
  • Change in iothalamate clearance before and after optional 12 week maintenance open label phase. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2008
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arginine Dietary Supplement: L-arginine
Arginaid (Novartis) 1 package (9.2g) bid for 7 days
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo powder 9.2g bid for 7 days

  Show Detailed Description

  Eligibility

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

Inclusion criteria

  1. Informed written consent
  2. Ages 18+ at the time of entry into the study
  3. Recipient of primary liver transplantation from a deceased or live donor

  4. Stable with satisfactory allograft function

    1. Total bilirubin < 2.5 mg/dl and
    2. Aminotransferase < x 3 upper limit of normal (e.g., ALT<120 IU/mL)
  5. Serum creatinine < 2.5 mg/dl without dialysis
  6. Maintenance immunosuppression including tacrolimus or cyclosporine

  7. Stable hemodynamic function

    1. Systolic blood pressure > 100 mmHg
    2. Resting pulse rate < 100

Exclusion criteria

  1. Recipient of combined liver-kidney transplantation
  2. Prior organ transplantation (i.e., exposure to calcineurin inhibitors)
  3. Established primary renal disease with active urinary sediments
  4. On-going renal replacement therapy
  5. Pulmonary hypertension (e.g., portopulmonary hypertension)
  6. Iodine allergy
  7. 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

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: W. Ray Kim, Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587418     History of Changes
Other Study ID Numbers: 06-007047, R21AT004174
Study First Received: December 21, 2007
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013