Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

Mycophenolic Acid Pharmacokinetics and Pharmacogenomics - Impact on the Clinical Outcomes of Patients With Severe Lupus Nephritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02453997
• Other study ID #: UW12-462
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2015
• Last updated: June 21, 2017
• Start date: October 2012
• Est. completion date: December 2019

Study information

• Verified date: June 2017
• Source: The University of Hong Kong
• Contact: Desmond Yap, MD
• Phone: 85222553879
• Email: desmondy[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12 hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. The MPA levels will be correlated with clinical parameters and outcomes. Pharmacogenomics studies will also be carried out and correlated with MPA exposure and clinical outcomes.

Description:

This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12 hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. The MPA levels will be correlated with clinical parameters and outcomes. For active patients, the MPA levels will be correlated with treatment response (CR or PR) and side effects. For patients in remission, the MPA levels will be correlated with drug tolerability and relapse. Pharmacogenomics studies will also be carried out and correlated with MPA exposure and clinical outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with recent active LN (biopsy-proven Class III/IV+/-V LN according to the ISN/RPS 2003 classifications within 3 months, with proteinuria >0.5 g/day and/or active urinary sediments) who receive corticosteroids and MMF (1g bd for 6 months) as induction treatment.

2. LN patients in remission (defined as proteinuria <0.5 g/day with inactive urinary sediment, prednisolone <10 mg/day) and on stable MMF maintenance (dose unchanged within the previous 3 months).

Exclusion Criteria:

1. Patients who receive enteric-coated mycophenolic acid (myfortic).

2. Patients who receive concomitant calcineurin inhibitors (e.g. cyclosporine or tacrolimus) other than corticosteroids and MMF.

3. Patients who receive concomitant medications which affect the MPA pharmacokinetics such as cholestyramine, acyclovir, and rifampicin.

4. Patients who are pregnant or lactating.

5. Patients with gastric emptying disorders

6. Patients with hepatic or biliary diseases

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, Hong Kong	Hong Kong
Hong Kong	United Christian Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	United Christian Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (0-12)		24 months
Secondary	Infection		24 months
Secondary	Gastrointestinal disturbances		24 months
Secondary	Complete or partial remission		24 months
Secondary	Relapse		24 months