rabbit antithymocyte globulin for Rejection; Transplant, Kidney

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
The Christ Hospital, Cincinnati, OH
Rejection; Transplant, Kidney
rabbit antithymocyte globulin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Belatacept With Early Steroid Withdrawal rATG and Everolimus in Renal Transplantation (BETTER Trial)

See full description

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

This trial is evaluating whether rabbit antithymocyte globulin will improve 1 primary outcome and 6 secondary outcomes in patients with Rejection; Transplant, Kidney. Measurement will happen over the course of 12 months.

12 and 24 months
# Patients with Incidence of Infections
# Patients with development of de novo donor specific antibody (DSA)
# of Patients with eGFR (MDRD) < 30 mL/min/1.73m2
Incidence of Biopsy-proven acute rejection (BPAR) by Banff 2007 criteria stratified by type (ACR, AMR, or Mixed rejection)
Incidence of graft survival censored by patients who died with functioning graft
12 months
Composite endpoint of patient death, graft loss, or eGFR (MDRD) < 45ml/min mL/min/1.73m2
24 months
Composite endpoint of patient death, graft loss, or estimated eGFR (MDRD) < 45 mL/min/1.73m2 at Month 24 post-transplantation

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Group E Bela/MMF
1 of 2
Group D Bela/EVR
1 of 2
Active Control
Experimental Treatment

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Rabbit Antithymocyte Globulin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Group D Bela/EVRrATG induction/belatacept/everolimus/early steroid withdrawal rATG 1.5mg/kg IV X 4 doses over 10 days belatacept 10mg/kg IV X 1 on POD 1, POD 5, weeks 2, 4, 8, and 12 then 5mg/kg IV X 1 on week 16 and then every 4 weeks thereafter Steroid taper x 5 days (500mg IV, 250mg IV, 125mg IV, 80mg po, 60mg po) Everolimus started within 24hours at 2mg BID and dosed to level 3-8ng/ml
Group E Bela/MMFrATG induction/belatacept/mycophenolate/chronic steroidsrATG 1.5mg/kg IV X 4 doses over 10 days belatacept 10mg/kg IV X 1 on POD 1, POD 5, weeks 2, 4, 8, and 12 then 5mg/kg IV X 1 on week 16 and then every 4 weeks thereafter Steroid taper x 5 days (500mg IV, 250mg IV, 125mg IV, 80mg po, 60mg po) and then 5mg po daily thereafter MMF 1gm BID started pre-op and then continued throughout study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belatacept
FDA approved
Everolimus
FDA approved
Antithymocyte immunoglobulin (rabbit)
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 and 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 and 24 months for reporting.

Who is running the study

Principal Investigator
R. A.
Prof. Rita Alloway, Professor of Medicine
University of Cincinnati

Closest Location

The Christ Hospital - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A patient who is receiving a renal transplant from a living or heart-beating donor. show original
Female patients who may become pregnant must have a negative pregnancy test within the last 48 hours before they are included in the study. show original
The patient has given written informed consent to participate in the study
People aged 18 or over who are male or female patients. show original

Patient Q&A Section

Can rejection; transplant, kidney be cured?

"While current research has established that rejection can be treated, no one is able to cure the problem of rejection. Because rejection occurs in all transplanted organs, it would be futile to attempt to cure it." - Anonymous Online Contributor

Unverified Answer

How many people get rejection; transplant, kidney a year in the United States?

"There were more post-transplant kidney rejection incidents for each year, which might be caused by better maintenance and better surveillance of kidney transplant recipients. Furthermore, the increasing incidence of graft dysfunction and acute rejections might be caused by the development of acute rejection episodes following renal transplantation, whereas the incidence of chronic kidney rejection remains stable." - Anonymous Online Contributor

Unverified Answer

What causes rejection; transplant, kidney?

"There are many causes of rejection that can lead to chronic kidney diseases and an increasing incidence in older transplant recipients. Most individuals with chronic renal replacement therapies develop new diseases during the follow-up while the first diagnoses of these diseases are mostly present in the early period after transplantation." - Anonymous Online Contributor

Unverified Answer

What is rejection; transplant, kidney?

"Rejection is a serious side effect of renal transplantation. It can be severe and life-threatening. Transplantation for this serious disease is a life-saving alternative to an unrelated donor." - Anonymous Online Contributor

Unverified Answer

What are common treatments for rejection; transplant, kidney?

"Rejections are not always associated with a specific treatment. A person's doctor will usually ask if they are taking any kind of immunosuppressant, when exactly the rejection is happening, and if a transplant is contemplated." - Anonymous Online Contributor

Unverified Answer

What are the signs of rejection; transplant, kidney?

"The most common presentations of [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant) rejection were cough suggestive of bronchiolitis obliterans, fever, and muscle acetic pains. Patients with mycotic or fungal rejection were usually afebrile but with mycotic symptoms whereas in patients with antibody-mediated rejection fever was usually the only sign, accompanied by a mycotic rash. In each presentation there were multiple causes for symptoms and the mainstay of treatment involved the cessation of high-dose immunosuppression and the introduction of specific immune-suppressing drugs." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in rabbit antithymocyte globulin for therapeutic use?

"The application of RANTES-Fc fusion protein of rabbit IgG2a in conjunction with RANTES-Fc can provide satisfactory immuno-compromised rabbit for therapeutic purposes in comparison with RANTES, as well as a strategy that can be employed in animal model." - Anonymous Online Contributor

Unverified Answer

Does rejection; transplant, kidney run in families?

"This review shows that the risk of transplant rejection does not run in families. Results from a recent paper does have some weaknesses, though. There are only three families included in the series but only a small number of families would be necessary to confirm the result of the present study. It does not seem likely that one of the families would have been selected for this case series if there really are no risk factors for transplant rejection. Further prospective studies with a larger sample size are needed." - Anonymous Online Contributor

Unverified Answer

How does rabbit antithymocyte globulin work?

"Findings from a recent study suggest that the treatment with RATG, either by high doses given in the first week after [transplant](https://www.withpower.com/clinical-trials/transplant)ation or alternatively by repeated low doses in the course of graft rejection after 6 months post-transplantation, has no clinically relevant effect on the time to hematopoietic reconstitution. The possibility that RATG modulates the proliferation of T lymphocytes and granulocytes cannot be excluded in some patients. Nevertheless, the fact that a high-dose regimen (≤150 mg/m2) is associated with a higher frequency of infections and rejection suggests that it should be used carefully in all patients." - Anonymous Online Contributor

Unverified Answer

What is rabbit antithymocyte globulin?

"There is currently no reliable evidence to support the use of RATG in human solid organ rejection. It is only used in an investigational setting by small-centre clinicians who are skilled in its use. Its use is not supported by evidence or practice guidelines and it is not routinely included in drug formulary listing by major healthcare organisations." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of rabbit antithymocyte globulin?

"RATG induction therapy rarely produces serious side effects in clinical settings. Mild and/or temporary side effects are commonly reported during the 2 week infusion period. Most patients tolerated these adverse events and tolerated the drug once the infusion was stopped." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of rejection; transplant, kidney?

"Rejection is the major cause of failure after [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation. However, the exact cause of rejection is unknown. Because we didn't use immunosuppressive agents, the precise cause of rejection may have been from both the disease itself and from the immunosuppressive therapy. We found that the underlying cause is related to the kidney's immune system and the patient's immune reaction to the transplanted organ. The most important and unexpected results of this study seem to have been the higher likelihood of primary graft nonfunction after kidney transplantation if the patient has active systemic lupus erythematosus and if a woman smokes." - 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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