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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT01377467
Eligibility Criteria:
The key inclusion criteria are:
1. Male or female adult de novo kidney, kidney-pancreas or kidney-islet, or kidney-liver transplant recipients
2. Functioning graft within 28 days after transplantation (creatinine having decreased to \<200 micromol/l without the need for dialysis)
3. Being on standard triple immunosuppression including a calcineurin antagonist (cyclosporine or tacrolimus), mycophenolate (MMF or MPA) and steroids, with or without induction treatment with basiliximab or anti-thymocyte globulin
Key exclusion criteria are:
1. Age \<18 years
2. Rising creatinine after initial drop \<200 micromol/l or creatinine \>200 micromol/l at baseline
3. Evidence of early acute rejection, either suspected clinically and/or proven by biopsy
4. Presence of severe osteoporosis as evidenced by a T score \<-4 at the hip, femoral neck or any of the 4 vertebrae L1 to L4
5. Evidence of severe hyper- or hypoparathyroidism (iPTH \>800 ng/l or \<10 ng/l)
6. Hypocalcemia (total calcium \<1.8 mmol/l) or hypercalcemia (total calcium \>2.7 mmol/l)
7. Steroid-free de novo immunosuppression scheme
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01377467
Study Brief:
Protocol Section:
NCT01377467