A Phase 2 interventional study of IVIg and rituximab in Kidney Failure, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
Some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. These patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. There are some medications and procedures that can decrease the antibody levels and this can increase the chance of finding a compatible donor for these patients. In this study the investigators will give two medications (IVIg and Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplant. After the investigators administer these medications, the investigators will continue to check for compatibility as organ offers are received. If a compatible organ offer is received, the investigators will perform the transplant using that organ. The investigators hypothesize that these medications will lower antibody levels and increase the chance that a these patients are able to receive a compatible kidney transplant.
2,030 studies on the registry are indexed under Renal Insufficiency; 168 are open to participants now.
This study's enrollment of 20 is below the median of 43 across 1,534 interventional studies indexed under Renal Insufficiency.
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Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Drug: IVIg and rituximab
Drug pages: Immunoglobulins, Intravenous · Rituximab
A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses. If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA).
Also known as: Gamunex and Rituxan
Time to Kidney Transplantation
Time frame: 4 months
Decrease in Panel Reactive Antibody
Time frame: 4 months
20 participants were enrolled.
| Milestone | IvIg With Rituximab |
|---|---|
| Started | 20 |
| Completed | 0 |
| Not completed | 20 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IvIg With Rituximab | — | — | — |
| Age, Categorical(Participants) | IvIg With Rituximab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | IvIg With Rituximab |
|---|---|
| Female | 13 |
| Male | 7 |
| Region of Enrollment(participants) | IvIg With Rituximab |
|---|---|
| United States | 20 |
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Immunoglobulins, Intravenous · Rituximab