Use of Cysteamine in the Treatment of Cystinosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Cystinosis is an inherited disease resulting in poor growth and kidney failure. There is no known cure for cystinosis, although kidney transplantation may help the renal failure and prolong survival. Both the kidney damage and growth failure are thought to be due to the accumulation of the amino acid cystine within the cells of the body. The cystine storage later damages other organs besides the kidneys, including the thyroid gland, pancreas, eyes, and muscle. The drug cysteamine (Cystagon; ProCysBi) is an oral medication given to patients with cystinosis prior to kidney transplantation. The drug works by reducing the level of cystine in the white blood cells and muscle tissue. The drug may also decrease levels of cystine in the kidneys and other tissues. This study has several goals: 1. Long-term surveillance of cysteamine treated patients. 2. Detection of new non-kidney complications of cystinosis. 3. Maintenance of a patient population for genetic testing (mutational analysis) of the cystinosis gene.\<TAB\>

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 115
Healthy Volunteers: f
View:

• Diagnosis of cystinosis, whether classical or one of the variants with later onset or no renal complications.

• Patients will be diagnosed as having cystinosis based upon a leucocyte cystine content greater than 1 nmol half-cystine/mg protein (normal, less than 0.2) and a typical clinical course.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
William A Gahl, M.D.
gahlw@mail.nih.gov
(301) 402-2739
Time Frame
Start Date: 1979-01-04
Participants
Target number of participants: 330
Treatments
Cystinosis
Patients with a diagnosis of cystinosis
Related Therapeutic Areas
Sponsors
Leads: National Human Genome Research Institute (NHGRI)

This content was sourced from clinicaltrials.gov