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Long-term outcomes in immunologically low-risk kidney transplant recipients using tacrolimus

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513394-42-01
Enrollment
66
Registered
2025-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Vaccination response

Brief summary

a. Renal function and proteinuria. (creatinin and CKD-EPI; urine spot protein/ creatinine) b. Patient survival. c. Rejection episodes. d. Infectious complications: opportunistic infections, use of antibiotics. e. Malignancy o Skin (diagnosed via routine dermatology check-up) o Non-skin.

Detailed description

Determination of donor-specific antibodies using Luminex single-antigen beads 4, 6 and 10 years after transplantation., Quantification of pneumococcal vaccination response 3 and 5 years after pneumococcal vaccination (year 4 and 6 after kidney transplantation) with the 23-serotype polyvalent pneumococcal vaccine; and 3 weeks and one year after booster vaccination 5 years after the initial vaccination.

Interventions

DRUGoplossing voor injectie in een voorgevulde spuit Pneumokokkenpolysacharidevaccin

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
a. Renal function and proteinuria. (creatinin and CKD-EPI; urine spot protein/ creatinine) b. Patient survival. c. Rejection episodes. d. Infectious complications: opportunistic infections, use of antibiotics. e. Malignancy o Skin (diagnosed via routine dermatology check-up) o Non-skin.

Secondary

MeasureTime frame
Determination of donor-specific antibodies using Luminex single-antigen beads 4, 6 and 10 years after transplantation., Quantification of pneumococcal vaccination response 3 and 5 years after pneumococcal vaccination (year 4 and 6 after kidney transplantation) with the 23-serotype polyvalent pneumococcal vaccine; and 3 weeks and one year after booster vaccination 5 years after the initial vaccination.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026