Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01015456
Other study ID # 2009-001
Secondary ID Lupus Research U
Status Terminated
Phase Phase 3
First received November 17, 2009
Last updated October 9, 2014
Start date January 2010
Est. completion date January 2013

Study information

Verified date October 2014
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.


Description:

In this study, there are two sub-studies in order to define secondary endpoints.

1. Pharmacokinetics study of Mycophenolic acid

2. Identify biomarkers for therapy-resistant prediction.

3. Identify biomarkers for predicting a loss of kidney function.


Recruitment information / eligibility

Status Terminated
Enrollment 59
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria:

- age 16 years of above at the time of screening

- ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements

- Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening

- Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (>90% chronic irreversible scarring)

- Relapse or resistant to (3 consecutive doses) IVCY

- Resistant lupus or Relapse lupus nephritis defined as follows:

- Increase in serum creatinine >/= 0.3 mg/dl or

- Increase in proteinuria > 1.5 g/day (which must have improved by = 50% in the preceding 3 months)

- Life-time cumulative dose of IVCY > 6 grams

- Female patients of childbearing potential must have a negative serum pregnancy

Exclusion Criteria:

Relates to SLE

- Diagnosis of rapid progressive glomerulonephritis (RPGN): doubling serum creatinine and/or crescentic glomeruli = 30%

- Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR < 30 ml/min(except creatinine clearance or MDRD-GFR > 50 ml/min in the 12 weeks prior to screening)

- History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.

- Severe extra-renal organ involvement

Related to Treatment

- Previous of any Mycophenolate groups in the 6 months prior to screening

- Treatment with any investigational drugs in the 3 months prior to screening

Related to General Health

- Pregnancy or breast feeding mothers.

- Concomitant condition which has required treatment moderate to high dose steroid in the 12 weeks prior to screening.

- Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.

- History of cancer, including solid tumors, hematological malignancies and carcinoma.

- Evidence of current abuse of drugs or alcohol.

Related to Laboratory Findings

- Neutrophile < 1,500/mm3, Hb < 7g/L, Platelet < 50,000/mm3 (except active SLE)

- Positive HBsAg or anti-HCV or anti-HIV.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
mycophenolate sodium
per oral, twice daily, for 12 months
cyclophosphamide
intravenous, monthly, for 6 months

Locations

Country Name City State
Thailand Nopparat Rajathani Bangkok
Thailand Khon Kaen University Khon Kaen
Thailand Thammasart University Pathumthani

Sponsors (3)

Lead Sponsor Collaborator
Chulalongkorn University Clinical Research Collaborative Network, Health Intervention and Technology Assessment Program (HITAP)

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis 12 months Yes
Secondary The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment 12 months No
Secondary The ratio of patients with declined renal function 12 months No
Secondary Time to remission 12 months No
See also
  Status Clinical Trial Phase
Recruiting NCT02936375 - The Iguratimod Effect on Lupus Nephritis (IGeLU) Phase 2
Completed NCT03597464 - Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin Phase 3
Recruiting NCT01226147 - Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis Phase 2
Completed NCT01206569 - Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis Phase 4
Active, not recruiting NCT00569101 - A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis Phase 2
Terminated NCT00368264 - TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL ) Phase 2/Phase 3
Completed NCT00371319 - Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis Phase 4
Completed NCT00298506 - Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V) N/A
Completed NCT00094380 - Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077) Phase 1/Phase 2
Terminated NCT04376827 - A Study of Guselkumab in Participants With Active Lupus Nephritis Phase 2
Completed NCT03610516 - Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis. Phase 2
Recruiting NCT03526042 - Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis N/A
Withdrawn NCT03859570 - Pentoxifylline in Lupus Nephritis Phase 4
Completed NCT03664908 - Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN)? N/A
Completed NCT01085097 - A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis Phase 2
Active, not recruiting NCT05704088 - SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients Phase 4
Not yet recruiting NCT06429800 - A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis Phase 1
Recruiting NCT02226341 - ACTHar in the Treatment of Lupus Nephritis Phase 4
Recruiting NCT02453997 - Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis N/A
Completed NCT01470183 - Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients N/A

External Links