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NCT01328834
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis
Phase 3 trial testing Tacrolimus Sustained-release Capsules (ADVAGRAF) in Nephritis, Lupus in 20 participants. Completed in 1 October 2011.
1 October 2011
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 January 2011 |
| Primary completion | 1 October 2011 |
| Estimated completion | 1 October 2011 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tacrolimus Sustained-release Capsules (ADVAGRAF) — full drug profile →
Conditions studied
- Nephritis, Lupus — all drugs for Nephritis, Lupus →
Sponsor
Sun Yat-sen University
Who can join
Adults 14 to 65, any sex, with Nephritis, Lupus. 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.
-
Remission rate (complete or partial remission)
Time frame: 6 months after therapy
Sponsor's own description
This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Juvenile-onset Systemic Lupus Erythematosus: Recent Advances in Pathogenesis and Treatment.
Natoli V, Charras A, Smith EM, Hedrich CM. · · 2025 · cited 1× · PMID 41410901 · DOI 10.1007/s11926-025-01207-7 -
Global perspectives on lupus nephritis: a review of clinical trials and therapeutic innovations.
Xu J, Zhang Y, Huang H, Cao Y. · · 2026 · PMID 42233033 · DOI 10.3389/fimmu.2026.1762892
Verify or expand the search:
- PubMed search for NCT01328834
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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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 NCT01328834 (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 Sun Yat-sen University
- Last refreshed: 1 November 2011
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/NCT01328834.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing