Phase
Condition
Kidney Failure (Pediatric)
Kidney Failure
Treatment
Cysteamine Bitartrate
N-Acetylcysteine Amide
Clinical Study ID
Ages > 10 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females, any race, ≥ 10 years of age.
Diagnosis of nephropathic cystinosis and able to cease cysteamine therapy for 2days.
Females will be nonpregnant and nonlactating, and females of childbearing potentialand males will agree to use contraception as detailed in the protocol.
Able to comprehend and willing to sign an informed consent /assent form and to abideby the study restrictions (travel as necessary, clinical phase 1 unit or similar forup to 3 days).
Exclusion
Exclusion Criteria:
Have undergone kidney transplantation.
Are receiving dialysis treatment.
History of significant hypersensitivity to NAC or any ingredient of NPI-001 oralsolution.
Participation in a clinical study involving administration of an investigationaldrug (new chemical entity) in the 30 days prior to Day 1.
Inability to provide blood samples, including difficulty with venous access.
Subjects who, in the opinion of the Investigator and/or Sponsor (or designee),should not participate in this study.
Study Design
Study Description
Connect with a study center
Children's Hospital at Westmead
Westmead, New South Wales 2145
AustraliaActive - Recruiting
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