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Trials - SLCTR/2018/021

Protocol Change

Date

2019-01-28


Protocol

No protocol changes


Item Changed

Secondary outcome(s) - Time 0f assessment(s)


Previous Version

At baseline, and then every 12 weeks for a total of 24 weeks. Secondary outcome 3 (hypersensitivity) will be assessed at the time of administration.


Next Version

Secondary outcome(s) Rate of decline of GFR [At baseline, and then every 12 weeks for a total of 24 weeks. ] Reduction of urine Cd level (cadmium, heavy metal) [At baseline, and then every 12 weeks for a total of 24 weeks. ] Safety outcomes – acute hypersensitivity reactions measured by clinical observation. [Assessed at the time of administration. ]