| CTRI Number |
CTRI/2019/07/020328 [Registered on: 23/07/2019] Trial Registered Prospectively |
| Last Modified On: |
02/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Anti-PLA2R antibody status in primary membranous nephropathy |
|
Scientific Title of Study
|
Anti-PLA2R antibody positivity and outcome in primary membranous nephropathy- a prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Indu R Rao |
| Designation |
Assistant Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Nephrology, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9592896393 |
| Fax |
|
| Email |
indurrao2006@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Indu R Rao |
| Designation |
Assistant Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Nephrology, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9592896393 |
| Fax |
|
| Email |
indurrao2006@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Indu R Rao |
| Designation |
Assistant Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Nephrology, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9592896393 |
| Fax |
|
| Email |
indurrao2006@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college, Manipal |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
N.A. |
| Type of Sponsor |
Other [None] |
|
|
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 Indu R Rao |
Kasturba Hospital |
Department of nephrology, OPD block, 1st floor,
Tiger circle road, Madhav Nagar, Manipal-576104
Udupi
KARNATAKA |
09592896393
indurrao2006@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N042||Nephrotic syndrome with diffuse membranous glomerulonephritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Those with biopsy proven primary membranous nephropathy |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Presence of active infection
3. Evidence of secondary cause of MN (e.g. hepatitis B, SLE, drugs, malignancy)
4. Estimated GFR (eGFR) ≤ 30 mL/min/1.73m2
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete/partial remission at 6 months
Complete remission (CR) : Proteinuria lesser than 0.3g/day or UPCR lesser than 0.3 mg/mg, with normalization of serum albumin (more than or equal to 3.5g/dL)
Partial remission : Reduction of 24 hour urine protein (or UPCR) to lesser than 50% of baseline to lesser than 3.5g/day (or UPCR lesser than 3.5mg/mg), but greater than 0.3g/day (or UPCR greater than 0.3mg/mg)
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Rate of eGFR decline
2. Anti-PLA2R levels at 6 and 12 months post-therapy
3. Frequency and time to relapse of nephrotic state
4. Serious adverse events: Any adverse event that results in death, is life-threatening, requires hospitalization or prolongs hospital stay (serious infections, myelotoxicity, malignancy, thromboembolic events)
5. Non-serious adverse events
|
Six and twelve months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2019 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
PRIMARY PURPOSE OF STUDY: Membranous nephropathy (MN) is one of the most common causes of nephrotic syndrome in adults. In majority of patients, it occurs in the absence of an identifiable predisposing disease (e.g. systemic lupus erythematosus {SLE}), infection (e.g. hepatitis B), drug (e.g. non-steroidal anti-inflammatory drug) or malignancy, and is termed primary. Recent evidence suggests that circulating auto-antibodies against podocyte surface antigen Anti-PLA2R and thrombospondin type 1 domain containing 7A (THSD7A) cause the disease in the majority of patients.Presently Anti PLA2R antibody titers are available for diagnosing primary membranous nephropathy. The Anti PLA2 R antibodies are positive in 70-80%% of Primary membranous nephropathy. The literature on response to therapy based on Anti PLA2 receptor antibody is lacking. So our present study would provide insight regarding the role of Anti PLA2 R antibody positivity in predicting the response to therapy and clinical outcomes in MN.
|