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

NCT00587418 | Completed DMC

• 2 other identifiers: 06-007047R21AT004174
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• Changes in eGFR before and after L-arginine

  7 days with option for 12 week maintenance phase

Secondary Outcomes (3)

• Urinary excretion of cGMP before and after L-arginine. Creatinine before and after L-arginine.

  7 days with option for 12 week maintenance phase

• Safety of oral L-arginine

  7 days with option for 12 week maintenance phase

• Change in iothalamate clearance before and after optional 12 week maintenance open label phase.

  12 weeks

Study Arms (2)

Arginine

EXPERIMENTAL

Dietary Supplement: L-arginine

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

L-arginine DIETARY_SUPPLEMENT

Arginaid (Novartis) 1 package (9.2g) bid for 7 days

Arginine

Placebo DIETARY_SUPPLEMENT

Placebo powder 9.2g bid for 7 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed written consent
• Ages 18+ at the time of entry into the study
• Recipient of primary liver transplantation from a deceased or live donor
• Stable with satisfactory allograft function
• Total bilirubin \< 2.5 mg/dl and
• Aminotransferase \< x 3 upper limit of normal (e.g., ALT\<120 IU/mL)
• Serum creatinine \< 2.5 mg/dl without dialysis
• Maintenance immunosuppression including tacrolimus or cyclosporine
• Stable hemodynamic function
• Systolic blood pressure \> 100 mmHg
• Resting pulse rate \< 100

You may not qualify if:

• 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 (e.g., portopulmonary hypertension)
• Iodine allergy
• Other systemic illness (e.g., infection) that require hospitalization care beyond 2 weeks after LTx

Sponsors & Collaborators

• Mayo Clinic: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• W. Ray Kim

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: September 3, 2012

Record last verified: 2012-08

Locations

US (1)