NCT06126380
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
Enrolling by Invitation
PHASE2Ages 18+InterventionalTreatmentEledon Pharmaceuticals
~132 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:AT-1501Tacrolimus
At a glance
Recruiting sites
0 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability - Incidence of Treatment Emergent Adverse Events
Measured over Assessed from date of enrollment through Month 48
+1 more outcome measured
Conditions
Where it's being run
43 sites across 28 statesCalifornia5
Spain5
France4
Georgia2
Illinois2
Minnesota2
Brazil2
District of Columbia1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Successfully completed qualifying Parent study, where entry into the OLE was offered;
Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent;
Agree not to participate in another interventional study while on treatment;
If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline, through 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6.
If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug.
Exclusion
Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator;
Met any of the stopping criteria or discontinued study drug in the Parent study;
Pregnant or breastfeeding.
What this trial measures
- Safety and Tolerability - Incidence of Treatment Emergent Adverse EventsAssessed from date of enrollment through Month 48
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
- Safety and Tolerability - Kidney Transplant Medication Side EffectsAssessed from date of enrollment through Month 48
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.