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Completed

NCT Number: NCT01203709

Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis

A trial of combination of two drugs for the treatment of refractory lupus nephritis.

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Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tuen Mun Hospital

Hong Kong, China

About this study

Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active nephritis documented by renal biopsy within 24 months of entry;
  • Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
  • Serum creatinine (Scr) less than 200umol/L.

Exclusion criteria

  • Previous intolerance to either MMF/Tac;
  • Scr >200umol/L;
  • Informed consent unavailable.

Treatment and study plan

low dose combination of MMF and Tac

Drug

mycophenolate mofetil 500mg BID + tacrolimus 2mg BID

Other names: Cellcept and Prograf

Primary outcomes

  1. Clinical remission rate

    Time frame: 12 months

Secondary outcomes

  1. Adverse events

    Time frame: 12 months

    adverse events experienced by patients as a measure of tolerability

Sponsors and collaborators

Lead sponsor

Tuen Mun Hospital

Other Gov

Registry information

Official study title

Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Sep 16, 2010
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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