Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT01106027
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age
* Has end stage renal disease (ESRD) and is to receive a kidney transplant from a deceased donor (DD) to whom he/she has a positive T or B cell crossmatch \>200 at the time of transplant and DSA demonstrated by solid phase assays.
* Willing to comply with the protocol
* Females of child-bearing potential must have a negative pregnancy test (serum β-HCG) and sexually active females must agree to use a reliable and medically approved method of contraception
* Willing and able to give written informed consent
* Vaccinated against Neisseria meningitides (quadrivalent vaccine), Pneumococcus and H. influenzae at least two weeks prior to beginning desensitization
Exclusion Criteria:
* Unstable cardiovascular condition
* Previous splenectomy
* Active bacterial or other infection which is clinically significant in the opinion of the investigator
* Known or suspected hereditary complement deficiency
* Participation in any other investigational drug study or was exposed to an investigational drug or device within 30 days of randomization
* Pregnant, breast-feeding, or intending to conceive during the course of the study, including a one month follow-up period after drug discontinuation
* Known hypersensitivity to the treatment drug or any of its excipients
* History of illicit drug use or alcohol abuse within the previous year
* History of meningococcal disease
* Medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, pose an added risk for the patient, or confound the assessment of the patient (e.g. severe cardiovascular or pulmonary disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01106027
Study Brief:
Protocol Section:
NCT01106027