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Belatacept for Immunosuppression

UT Southwestern Medical Center, Dallas, TX
ImmunosuppressionBelatacept - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if a patient's DNA can predict if they will have a successful kidney transplant with just one immunosuppressive drug, instead of the multiple drugs typically required.

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Similar Trials

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Normal Saline Group
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belatacept
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Total Lymphoid irradiation

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 12 months after the start of immunosuppression wean

Month 12
Number of patients with acute kidney graft rejection
Month 12
Mean prediction score of allograft loss as measured by iBox
Negative predictable value as measured by AlloMap®
Number of participants with Proteinuria
Number of participants with appearance of de-novo donor specific antibodies (dnDSA)
Number of patients with kidney graft failure
Month 36
Number of patients who died
Month 12
Mean change in Estimated Glomerular Filtration Rate (eGFR)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Normal Saline Group
1
belatacept
1
Total Lymphoid irradiation

Side Effects for

Belatacept
67%COPD exacerbation
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT02078193) in the Belatacept ARM group. Side effects include: COPD exacerbation with 67%.

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

Immunosuppression Taper
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Belatacept · No Placebo Group · Phase 4

Immunosuppression Taper
Drug
Experimental Group · 1 Intervention: Belatacept · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belatacept
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months after the start of immunosuppression wean

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
971 Previous Clinical Trials
1,115,786 Total Patients Enrolled
CareDxIndustry Sponsor
25 Previous Clinical Trials
21,699 Total Patients Enrolled
4 Trials studying Immunosuppression
1,000 Patients Enrolled for Immunosuppression
Cyrus Feizpour, MDPrincipal InvestigatorUT Southwestern Medical Center
David Wojciechowski, DOPrincipal InvestigatorUT Southwestern Medical Center

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You cannot receive an organ transplant from a living or deceased donor who is not a close enough genetic match.
You have had a kidney transplant within the past 9 months.
References

Frequently Asked Questions

Are there any vacancies for prospective participants in this experiment?

"Yes, according to clinicaltrials.gov records this medical trial is currently enrolling candidates with the original posting taking place on July 28th 2021 and edits being made as recently as December 30th 2021." - Anonymous Online Contributor

Unverified Answer

Are there any prior studies that have incorporated Belatacept in their research?

"Currently, 12 studies for Belatacept are active with 1 trial in the third stage. San Francisco is a major centre for this medication's clinical trials; however, there are 48 total locations across America running these experiments." - Anonymous Online Contributor

Unverified Answer

What risks are associated with the usage of Belatacept?

"The safety of Belatacept was assessed at 3, denoting its Phase 4 classification and consequently approved status." - Anonymous Online Contributor

Unverified Answer

How many participants are taking part in this clinical trial?

"Affirmative. According to the data posted on clinicaltrials.gov, this study that was published on July 28th 2021 is still recruiting patients and has opened 1 site for enrollment of 25 participants." - Anonymous Online Contributor

Unverified Answer

Does this experiment herald a new era of research?

"Belatacept has undergone a series of trials since its initial study in 2018, which was sponsored by Rho Federal Systems Division, Inc. Following the first Phase 1 trial involving 6 participants, Belatacept received approval for widespread use and currently there are 12 active investigations underway across 8 different nations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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