| CTRI Number |
CTRI/2013/12/004179 [Registered on: 02/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
23/12/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Cyclophosphamide and Mycophenolate Mofetil in patients with kidney involvement in Systemic Lupus Erythematosus. |
Scientific Title of Study
Modification(s)
|
Randomized Controlled Trial of Low-Dose Intravenous Cyclophosphamide versus Oral Mycophenolate Mofetil in Treatment of Lupus Nephritis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Rathi |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drmanishrathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Rathi Guide |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drmanishrathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Goyal |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
ajaygoyaldr@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Manish Rathi |
| Address |
Assistant Professor,
Department of Nephrology,
Post Graduate Institute of Medical Education and Research,
Chandigarh, India-160012,
|
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manish Rathi |
Department of Nephrology |
Post Graduate Institute of Medical Education and Research,
Sector-12, Chandigarh, India-160012
Chandigarh
CHANDIGARH |
0172-2756734
drmanishrathi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Systemic lupus erythematosus-Lupus nephritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cyclophosphamide |
Six fortnightly intravenous pulses at a fixed dose of 500 mg i.e six doses over a period of three months to be followed by Azathioprine 2mg/kg/day as maintenance therapy |
| Comparator Agent |
Mycophenolate mofetil |
Target dosage 1.5-3g/day orally in two to three divided doses for six months to be followed by Azathioprine 2mg/kg/day as maintenance therapy |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 12 to 65 year with diagnosis of Systemic Lupus Erythematosus by American College of Rheumatology criteria (ACR)
2. Kidney biopsy diagnosis of Lupus nephritis class III, IV, V, III+V, IV+V
3.Serum creatinine <3.0 mg/dl.
|
|
| ExclusionCriteria |
| Details |
1. Severe proliferative lupus nephritis on histology (eg. Crescentic glomerulonephritis)
2. Ongoing infection
3. Pregnant females
4. Previously received immunosuppressive treatment
5. Patient not giving consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
-decrease in the urine protein/creatinine ratio to less than 3 in subjects with baseline nephrotic range proteinuria
-decrease in the urine protein/creatinine ratio by more than 50% in subjects with sub-nephrotic proteinuria (3 urine protein/creatinine ratio).
-Stabilization of serum creatinine (i.e., a week 24 serum creatinine level ±25% of baseline) or improvement.
|
3 months and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Complete renal remission, defined as return to normal serum creatinine, proteinuria ≤500mg/24hr and inactive urine sediment
- Systemic disease activity (assessed by Safety of Exogenous Estrogens in Lupus Erythematosus National Assessment/Systemic Lupus Erythematosus Disease Activity Index)
- Adverse events.
|
3 months and six months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is an open label, prospective, randomized, two-arm, parallel group study aimed
at comparing the efficacy and safety of oral Mycophenolate Mofetil for 6 months
with low-dose intravenous Cyclophosphamide (Euro-Lupus regimen) for three
months in patients who have a kidney biopsy diagnosis of
lupus nephritis (Class III/IV/V). The primary end point is a pre-specified
decrease in proteinuria and stabilization or improvement in serum creatinine at
the end of induction regimen. Secondary end points include complete renal
remission, systemic disease activity (assessed by Safety of Exogenous Estrogens
in Lupus Erythematosus National Assessment/Systemic Lupus Erythematosus Disease
Activity Index) and adverse events at the end of induction regimen. The trial
is a non-inferiority trial with the hypothesis that both the drugs perform
equally good in achieving the target end-points with comparable adverse
reactions.
|