Who is sponsoring NCT01436305?

NCT01436305 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT01436305 study?

NCT01436305 studies Kidney Transplantation, Renal Transplantation.

What drugs are being tested in NCT01436305?

Interventions: Alemtuzumab, MMF, Basiliximab, Short-term Tac, tacrolimus, Belatacept, methylprednisolone.

What is the status of NCT01436305?

NCT01436305 is currently TERMINATED.

Last reviewed 2017-08-29 · How we verify

Optimization of NULOJIX® (Belatacept) Usage as a Means of Avoiding CNI and Steroids in Renal Transplantation (CTOT-10)

NCT01436305 Phase 2 TERMINATED Results posted

The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would minimize serious long term side effects associated with anti-rejection medications while still protecting the new kidney from damage. The researchers also wanted to learn more about the safety of this treatment and long term health of the transplanted kidney.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	TERMINATED
Enrolment	19
Start date	2011-09
Completion	2015-04

Conditions

Kidney Transplantation
Renal Transplantation

Interventions

Alemtuzumab
MMF
Basiliximab
Short-term Tac
tacrolimus
Belatacept
methylprednisolone

Primary outcomes

Mean Glomerular Filtration Rate (GFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 — Week 52
GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.

Countries

United States