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Towards a further extension of the potential donor pool for highly sensitized patients.

Towards a further extension of the potential donor pool for highly sensitized patients. - Extension of the potential donor pool for highly sensitized patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30695
Enrollment
21
Registered
2007-08-13
Start date
2007-07-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplantation

Interventions

Mainly the selection of suitable donors will change for a certain patient. The medical procedure of the transplantation will not differ from that of other renal transplant recipients besides the fac

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Older than 18 years. Patients with renal failure on the Eurotransplant kidney waiting list. PRA in historical sera higher than 85%. More than 1 year on the AM list. A signed "informed consent" form.

Exclusion criteria

Exclusion criteria: 1) Patients with severe gastrointestinal disorders, that interfere with their ability to receive or absorb oral medication and patients with severe diarrhea. 2) Patients with active peptic ulcer disease. 3) Patients or their donors with serologic evidence of HIV, HCV or HBsAg in the past. 4) Patients with malignancies (current or history within last 5 years) except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. 5) Patients with systemic infection requiring therapy at the time of entry in the study. 6) Patients with any form of substance abuse or psychiatric disorder which in the opinion of the investigator might invalidate patients communication with the clinician.

Design outcomes

Primary

MeasureTime frame
Finding new Acceptable HLA mismatches and leading to an increased chance to get an organ offer.

Secondary

MeasureTime frame
Secondary objectives are patient and graft survival, graft function as assessed by calculated creatinine clearance, proteinuria, the number and severity of acute (antibody mediated) rejections, blood pressure (antihypertensive treatment), monitoring of infections and the occurrence of malignancies.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)