Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure |
Drug: IVIg and rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of IVIg and Rituximab for Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates |
- Time to kidney transplantation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Decrease in panel reactive antibody [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | September 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
-
Drug: IVIg and 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).
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages 18-75
- End-stage renal disease on dialysis
- PRA > 60%
- Have been evaluated for and are currently listed for deceased donor renal transplantation
Exclusion Criteria:
- Have contraindication to transplantation
- Have contraindication to receiving IVIG
- Have allergy to IVIG
- Have received IVIG for desensitization previously without effect
- Pregnant women or those intending to become pregnant
Contacts and Locations More Information
No publications provided
| Responsible Party: | Andrew L. Singer, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00986947 History of Changes |
| Other Study ID Numbers: | NA_00027111 |
| Study First Received: | September 29, 2009 |
| Last Updated: | August 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Immunoglobulins, Intravenous Rituximab Urologic Diseases Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013