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NCT06676696
Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure
Phase 4 trial testing Continue low dose calcineurin inhibitor (CNI) in Renal Failure , Chronic in 202 participants. Currently enrolling.
31 January 2028
Quick facts
| Lead sponsor | Hospital Universitari Vall d'Hebron Research Institute |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 202 |
| Start date | 22 January 2024 |
| Primary completion | 31 January 2028 |
| Estimated completion | 31 January 2028 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Continue low dose calcineurin inhibitor (CNI) — full drug profile →
- Calcineurin inhibitor withdrawal at 6 months — full drug profile →
Conditions studied
- Renal Failure , Chronic — all drugs for Renal Failure , Chronic →
- Graft Failure — all drugs for Graft Failure →
- Graft Rejection — all drugs for Graft Rejection →
- Allograft — all drugs for Allograft →
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Who can join
18 and older, any sex, with Renal Failure , Chronic or Graft Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (\> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months. The main question this study aims to answer is: Does maintaining long-term immunosuppression in patients with a late renal graft failure (\> 3 months) safely reduce the risk of HLA sensitization? To answer this question, patients will be assigned to a control arm or investigational arm: * Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months. * Patients assigned to the investigatonal arm will continue immunosuppressant treatment at low doses for 2 years. Patients recruited in this clinical trial will be followed for up to 2 years. During this time, patients will visit the clinic every 3 months for checkups and tests.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06676696
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Renal Failure , Chronic
Currently open trials in the same condition.
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Other Hospital Universitari Vall d'Hebron Research Institute trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06676696 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute
- Last refreshed: 6 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06676696.
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