Trial Outcomes & Findings for Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation (NCT NCT02974686)

NCT ID: NCT02974686

Last Updated: 2020-08-10

Results Overview

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

3 months

Results posted on

2020-08-10

Participant Flow

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Participant milestones

Participant milestones
Measure
Interventional Everolimus (EVR)
Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus Everolimus
Prior Agent Mycophenolic Acid (MPA)
Patient will have baseline data collected while on MPA for comparison with EVR Mycophenolic Acid
Overall Study
STARTED
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 3 months

Population: Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 6, and 12 months

Population: Trial was terminated with only 1 participant enrolled, no data is reported to protect patient confidentiality

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Trial was terminated with only 1 participant enrolled, no data is reported to protect patient confidentiality

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Outcome measures

Outcome data not reported

Adverse Events

Interventional (EVR)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Prior Agent (MPA)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. R. Delos Santos

Washington University

Phone: 314-362-8351

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place