Kidney Transplantation Clinical Trial
Official title:
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation
Verified date | November 2016 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.
Status | Completed |
Enrollment | 140 |
Est. completion date | |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - First kidney transplantation - Male and female patients - Between 18 and 65 years old Exclusion Criteria: - Patient in need of multi-organ transplant - Patients with history of cardiac arrest - Patients with any past or present malignancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Novartis Pharmaceuticals |
Tedesco-Silva H, Mourad G, Kahan BD, Boira JG, Weimar W, Mulgaonkar S, Nashan B, Madsen S, Charpentier B, Pellet P, Vanrenterghem Y. FTY720, a novel immunomodulator: efficacy and safety results from the first phase 2A study in de novo renal transplantatio — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant | |||
Primary | Permanent resumption of dialysis within 6 months post transplant | |||
Primary | Surgical removal of graft within 6 months post transplant | |||
Primary | Death within 6 months post transplant | |||
Primary | Withdrawal of consent, death, or lost to follow up within 6 months post transplant | |||
Secondary | IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant | |||
Secondary | Permanent resumption of dialysis within 12 months post transplant | |||
Secondary | Surgical removal of graft within 12 months post transplant | |||
Secondary | Death within 12 months post transplant | |||
Secondary | Withdrawal of consent, death, or lost to follow up within 12 months post transplant | |||
Secondary | Serum creatinine, estimated creatinine clearance, abnormalities of vital signs and laboratory variables and measurements of urine protein at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12. | |||
Secondary | FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Day 28, Months 6 and 12 | |||
Secondary | Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12. |
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