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Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis

Sponsored by FDA Office of Orphan Products Development

Phase Quota
Phase N/A

OBJECTIVES: I. Compare the efficacy of two doses of folic acid in normalizing plasma total homocysteine concentration in patients with end stage renal disease receiving regular hemodialysis therapy resulting in hyperhomocysteinemia. II. Determine the requirement of co-supplementation with extra pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) daily in these patients. III. Assess the safety and tolerability of this therapy in these patients.

Study Start Date: June 1999

Estimated Completion Date: September 2000

Specialties: Physician Assistant: Clinical Pharmacology,Nephrology Internal Medicine: Clinical Pharmacology,Nephrology/Urology Nephrology: Chronic Dz/Renal Failure,Dialysis,Pharmacology/kinetics

Interventions

  • Drug: cyanocobalamin
  • Drug: folic acid
  • Drug: pyridoxine

Inclusion criteria

PROTOCOL ENTRY CRITERIA:

  • Disease Characteristics:
    • Diagnosis of end stage renal disease requiring regular hemodialysis treatment 3 times weekly
    • Baseline predialysis total homocysteine concentration in plasma greater than 16 micromoles/L
    • No prior or concurrent pernicious anemia
    • No blood smear examination showing unexplained macrocytosis
  • Prior/Concurrent Therapy:
    • Chemotherapy: No concurrent chemotherapy for cancer
    • Other: No concurrent levodopa or carbidopa No concurrent penicillamine or trimethoprim-sulfonamide combination No concurrent antiviral therapy No concurrent anticonvulsants
  • Patient Characteristics:
    • Hematopoietic: Hematocrit at least 25%
    • Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No Parkinson's disease No convulsions or epilepsy requiring treatment No lactose intolerance or allergy to milk products No history of allergic sensitization following administration of folic acid, pyridoxine (vitamin B6), or cyanocobalamin (vitamin B12) No vitamin B12 concentration below lower limit of normal (150 picamole/L) No untreated hypothyroidism or psoriasis

Exclusion criteria

  • N/A

Study Locations And Contact Information

  • Georgetown University Medical Center, Washington District of Columbia

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