Last reviewed · How we verify
NCT01678937
Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents
trial testing Blood Draw - Rapamycin in Liver Transplant Rejection in 31 participants. Completed in 1 September 2008.
1 May 2008
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 31 |
| Start date | 1 September 2007 |
| Primary completion | 1 May 2008 |
| Estimated completion | 1 September 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Blood Draw - Rapamycin
- Blood Draw from Control Subjects
- Blood Draw - CyA
- Blood Draw - Tacrolimus
- Blood Draw - MMF
- Blood Draw - Rapamycin
Conditions studied
- Liver Transplant Rejection — all drugs for Liver Transplant Rejection →
- Immunosuppression — all drugs for Immunosuppression →
Sponsor
Northwestern University
Who can join
18 and older, any sex, with Liver Transplant Rejection or Immunosuppression. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Track interval outcome measures for development of higher percentages of FOXP3+ T1 regulatory cells in stable liver transplant recipients on rapamycin or MMF monotherapy compared to CNI monotherapy.
Time frame: Two weeks prior to conversion, Months 3 & 6 following conversion
* Dendritic cell assays: myeloid vs. lymphoid (CD11c; CD123); maturation and ability to process antigens (CD83; CD205); markers that have been shown to induce regulatory T cells (ILT3; ILT4). * Regulatory/Suppressor Cells (CD4+CD25+FOXP3+CD127low; and CD8+ CD28- FOXP3+CD127low cells). * Liver function and drug levels. -
Track interval outcome measures for development of higher percentages of FOXP3+ T regulatory cells in liver transplant recipients after conversion from CNI to rapamycin comparing to MMF monotherapy.
Time frame: Two weeks prior to conversion, Months 3 & 6 following conversion
* Dendritic cell assays: myeloid vs. lymphoid (CD11c; CD123); maturation and ability to process antigens (CD83; CD205); markers that have been shown to induce regulatory T cells (ILT3; ILT4). * Regulatory/Suppressor Cells (CD4+CD25+FOXP3+CD127low; and CD8+ CD28- FOXP3+CD127low cells).
Sponsor's own description
This study is being done with the purpose of trying to understand if and why transplant recipients may develop tolerance to their transplanted organ. Tolerance means being able to lower or take away immunosuppression (anti-rejection medications) without causing organ rejection.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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CD83: Activation Marker for Antigen Presenting Cells and Its Therapeutic Potential.
Li Z, Ju X, Silveira PA, Abadir E, et al · · 2019 · cited 125× · PMID 31231400 · DOI 10.3389/fimmu.2019.01312 -
Molecular networks of FOXP family: dual biologic functions, interplay with other molecules and clinical implications in cancer progression.
Kim JH, Hwang J, Jung JH, Lee HJ, et al · · 2019 · cited 85× · PMID 31815635 · DOI 10.1186/s12943-019-1110-3 -
Clinical and Basic Research Progress on Treg-Induced Immune Tolerance in Liver Transplantation.
Ni X, Wang Q, Gu J, Lu L. · · 2021 · cited 21× · PMID 34093514 · DOI 10.3389/fimmu.2021.535012
Verify or expand the search:
- PubMed search for NCT01678937
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Liver Transplant Rejection
Currently open trials in the same condition.
- NCT07053488 — CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection · Phase 1, PHASE2 · recruiting
- NCT06400771 — Safety of DNP007 in Healthy Subjects · Phase 1 · recruiting
- NCT05325073 — Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients · Phase 4 · active not recruiting
- NCT06153641 — Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients · active not recruiting
Other Northwestern University 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 NCT01678937 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northwestern University
- Last refreshed: 14 April 2015
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/NCT01678937.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing