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CompletedNCT00239785Updated Aug 22, 2017

Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

A Phase 3 interventional study of FTY720 in Renal Transplantation, sponsored by Novartis Pharmaceuticals. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
684
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant

02

Conditions studied

  • Renal Transplantation

Keywords

  • Transplantation, kidney, and organ transplant.
03

In context

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All

Eligibility criteria

Inclusion Criteria

  • Male and female patients of any race between 18 to 65 years old (inclusive)
  • Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation
  • Patients who gave written informed consent to participate in the study Exclusion Criteria
  • Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
  • Graft cold ischemia time greater than 40 hours.
  • Patients with pulse rate \< 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
684 participants

Interventions

  • DrugFTY720
06

What researchers measure

Primary outcomes

  1. IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant

  2. Permanent resumption of dialysis within 12 months post transplant

  3. Surgical removal of graft within 12 months post transplant

  4. Death within 12 months post transplant

  5. Withdrawal of consent, death, or lost to follow up within 12 months post transplant

Secondary outcomes

  1. FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12

  2. Serum creatinine

  3. Cystatin C at months 3, 6, and 12

  4. Proteinuria at day 28, months 6 and 12

  5. Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00239785
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 17, 2005
Start date
Apr 2003
Primary completion
Apr 2005
Last update
Aug 22, 2017

Study contacts

Novartis
study director · Novartis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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