Last reviewed · How we verify
NCT01680952
Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients
Phase 4 trial testing A) TEST in Kidney Transplant Patients in 158 participants. Completed in 1 January 2016.
1 January 2016
Quick facts
| Lead sponsor | Yonsei University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 158 |
| Start date | 1 September 2012 |
| Primary completion | 1 January 2016 |
| Estimated completion | 1 January 2016 |
| Sites | 7 locations across South Korea |
Drugs / interventions tested
- A) TEST — full drug profile →
- B) CONTROL
Conditions studied
- Kidney Transplant Patients — all drugs for Kidney Transplant Patients →
Sponsor
Yonsei University
Who can join
20 and older, any sex, with Kidney Transplant Patients. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Failure rate in effectiveness of up to 12 months after kidney transplant
Time frame: 12 months after kidney transplant
1. Biopsy confirmed acute rejection 2. Subjects and graft survival 3. Glomerular filtration rate (GFR) 4. 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.
Sponsor's own description
This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial.
Huh KH, Lee JG, Ha J, Oh CK, et al · · 2017 · cited 16× · PMID 28810721 · DOI 10.1093/ndt/gfx093
Verify or expand the search:
- PubMed search for NCT01680952
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Kidney Transplant Patients
Currently open trials in the same condition.
- NCT05039788 — Observational Single-center Study of the Relationship Between Arterial Hypertension and Hypervolemia Defined by Self-mea · recruiting
Other Yonsei University trials
Trials by the same sponsor.
- NCT07547592 — Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma · Phase 2 · not yet recruiting
- NCT07524101 — Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD · NA · not yet recruiting
- NCT07506629 — Adductor Canal Block Methods in Bilateral Total Knee Arthroplasty · NA · not yet recruiting
- NCT07515716 — Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia · NA · not yet recruiting
- NCT07507188 — Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients · Phase 2 · not yet recruiting
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 NCT01680952 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Yonsei University
- Last refreshed: 7 March 2016
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/NCT01680952.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing