| CTRI Number |
CTRI/2023/12/060561 [Registered on: 20/12/2023] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
A Study of Zetomipzomib (KZR616) in Patients with Active
Lupus Nephritis |
|
Scientific Title of Study
|
A Phase 2b, Randomized, Controlled Double-blind,
Multicenter Study Comparing the Efficacy and Safety of
Zetomipzomib (KZR-616) 30 mg or 60 mg with Placebo
in Patients with Active Lupus Nephritis |
| Trial Acronym |
PALIZADE |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2022-502227-22-00 |
EudraCT |
| NCT05781750 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Chitgupi |
| Designation |
Country Head - Clinical Management |
| Affiliation |
PPD Pharmaceutical development Pvt Ltd. |
| Address |
PPD Pharmaceutical development Pvt Ltd., 101, A Wing, Fulcrum Hiranandani Business Park, Andheri, Mumbai
Mumbai
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
|
| Email |
rashmi.chitgupi@ppd.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Chitgupi |
| Designation |
Country Head - Clinical Management |
| Affiliation |
PPD Pharmaceutical development Pvt Ltd. |
| Address |
PPD Pharmaceutical development Pvt Ltd., 101, A Wing, Fulcrum Hiranandani Business Park, Andheri, Mumbai
Mumbai
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
|
| Email |
rashmi.chitgupi@ppd.com |
|
|
Source of Monetary or Material Support
|
| Kezar Life Sciences, Inc.
4000 Shoreline Court, Suite 300
South San Francisco, CA 94080 |
|
|
Primary Sponsor
|
| Name |
Kezar Life Sciences, Inc. |
| Address |
4000 Shoreline Court, Suite 300
South San Francisco, CA 94080 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
Argentina
Australia
Brazil
China
Colombia
Croatia
Germany
Greece
Guatemala
India
Malaysia
Mexico
Peru
Philippines
Portugal
Republic of Korea
Serbia
Singapore
South Africa
Spain
Taiwan
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 20 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand Chellappan |
All India Institute of Medical Sciences |
Plot no - 2, Sector – 20, Sumthana, MIHAN, Nagpur - 441108, Maharashtra, India
Nagpur
MAHARASHTRA |
7499578408
anandchellappan@aiimsnagpur.edu.in |
| Dr Vinay Rathore |
All India Institute of Medical Sciences |
Gate No. - 4, D
Block, Room No. -
420, Tatibandh, GE
Road, Raipur492099
Raipur
CHHATTISGARH |
9914699651
vinayrathoredm@aiimsraipur.edu.in |
| Dr Praveen Pratap Jadhav |
Assured Care Plus Hospital |
Clinical Research
Department
4th & 5th floor, Star
Plus Complex, Lam Road, Near
Muktidham Temple,
MNC Divisional Office, Nashik Road
Nashik
MAHARASHTRA |
9822055612
drpraveenjadhav@rediffmail.com |
| Dr Suceena Alexander |
Christian Medical College Vellore Ranipet Campus |
Department of
Nephrology Unit -
3, Kilminnal Village,
Ranipet District
Vellore
TAMIL NADU |
9894519136
suceena@gmail.com |
| Dr Vinod Pandirikkal Baburajan |
Elite Mission Hospital |
Koorkenchery,
Thrissur
Thrissur
KERALA |
4872436100
chinthavinod@sify.com |
| Dr Dibyendu Mukherjee |
Fortis Hospital |
Department of Rheumatology,
Fortis Healthcare Limited,
730, Anandapur, EM Bypass Road, Kolkata – 700107, West Bengal.
Kolkata
WEST BENGAL |
9830030238
dr_dmuk@yahoo.co.in |
| Dr Atanu Pal |
Institute of Post Graduate Medical Education & Research and SSKM Hospital |
Department of Nephrology,
Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A.J.C Bose Road, Kolkata – 700020, West Bengal, India.
Kolkata
WEST BENGAL |
9433121697
dratanupal@gmail.com |
| Dr Smruti Ramteke |
Jasleen Hospital |
Clinical Trial Department, 1st Floor, Room no. 1,
Opp to Big Bazar,
Panchasheel
Ssquare, Dhantoli,
Nagpur-440012
Nagpur
MAHARASHTRA |
9823514680
sramteke@rediffmail.com |
| Dr Prakash Pralhad Khetan |
KIMS - Kingsway Hospital |
44, Kingsway, Near
Kasturchand Park,
Nagpur-440001
Nagpur
MAHARASHTRA |
9823071748
prakash.khetan@kimskingsway.com |
| Dr Ritesh Vernekar |
KLES Dr Prabhakar Kore Hospital & Medical Research Centre |
Nehrunagar,
Belagavi-590010
Belgaum
KARNATAKA |
9449061633
riteshvernekar@gmail.com |
| Dr Sarath Chandra Mouli Veeravalli |
Krishna Institute of Medical Sciences Limited |
Department of
Rheumatology and
Clinical Immunology, 1-8-31/1,
Minister Road, Secunderabad
Hyderabad
TELANGANA |
9866000685
sarath10@hotmail.com |
| Dr Sudhir Gajanan Kulkarni |
MGM Medical College & Hospital |
Department of Pharmacology, Building B, Fourth Floor,
N-6, CIDCO,
Chhatrapati
Sambhajinagar-
431003
Aurangabad
MAHARASHTRA |
2406601100
sudhirkul1979@gmail.com |
| Dr Bankimchandra Nanubhai Desai |
Nirmal Hospital Pvt Ltd |
Ring Road, Surat –
395002
Surat
GUJARAT |
9979530073
drbankim.desai@gmail.com |
| Dr Vishnu Sharma |
Panchshil Hospital |
second Floor, Room 304, Research Department, Near Canara bank, Highway, Ramnagar, Sabarmati,
Ahmedabad -380005
Ahmadabad
GUJARAT |
8511555477
drvishnusharma@yahoo.co.in |
| Dr Tukaram Jamale |
Seth GSMC And KEM Hospital |
Parel, Mumbai
Ward 34A, third floor, Old building, Department of Nephrology, Seth GSMC And KEMH, Mumbai - 400012, Maharashtra, India
Mumbai
MAHARASHTRA |
9167460362
tukaramjamale@yahoo.co.in |
| Dr Dhaiwat Shukla |
Sheth Vadilal Sarabhai General Hospital |
Madalpur Gam, Paldi Road, Ellisbridge, Ahmedabad-380006, Gujarat, Indi
Ahmadabad
GUJARAT |
8980024107
drdhaiwatshukla89@gmail.com |
| Dr Anurag Gupta |
Sir Ganga Ram Hospital |
Department of Nephrology, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India.
New Delhi
DELHI |
8800260446
dranuragg1@yahoo.com |
| Dr Dhananjai Agrawal |
SMS Superspeciality Hospital |
Department of Nephrology, Attached to SMS Medical College, Vivekanand
Marg, Jaipur-
302001
Jaipur
RAJASTHAN |
9887870552
dhananjaynephro@gmail.com |
| Dr Siddharth Hariprakash Jain |
Unity Hospital, Unity Trauma Center and ICU |
Clinical Research Department, Nr. D.R. World,
Opp Raghuvir
Business Empire,
Aai Mata Road,
Parvat Patiya, Surat-
395010
Surat
GUJARAT |
9909928114
drsiddharthhjain@gmail.com |
| Dr Rajasekara Chakravarthi M |
Yashoda Hospitals |
Hitec City, Cyber
Towers to JNTU
Road,Hyderabad
Hyderabad
TELANGANA |
9391059322
rajasekarac@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 20 |
| Name of Committee |
Approval Status |
| Ethics Committee, Sir Ganga Ram Hospital, Sir Ganga Ram Hospital |
Submittted/Under Review |
| Fortis Hospital Ethics Committee, Fortis Hospital |
Submittted/Under Review |
| Institute Ethics Committee, AIIMS Raipur |
Approved |
| Institutional Ethics Committee for Clinical trials (IECCT), AIIMS, Nagpur |
Submittted/Under Review |
| Institutional Ethics Committee-I |
Submittted/Under Review |
| Institutional Ethics Committee Assured Care Plus Hospital |
Approved |
| Institutional Ethics Committee Elite Mission Hospital |
Approved |
| Institutional Ethics Committee, KLE University’s KLE Dr PK Hospital and MRC |
Submittted/Under Review |
| Institutional Ethics Committee, SMS Medical College & Attached Hospital |
Submittted/Under Review |
| Institutional Review Board (IRB) Christian Medical College Vellore |
Submittted/Under Review |
| IPGME&R Research Oversight Committee (Institutional Ethics Committee For Research Involving Human Subjects) |
Approved |
| Jasleen Hospital Ethics Committee Opp |
Approved |
| KIMS Ethics Committee, Krishna Institute of Medical Sciences |
Approved |
| Kingsway Hospital Ethics Committee |
Approved |
| MGM Ethics Committee for Research on Human Subject |
Approved |
| Nirmal Hospital Pvt Ltd Ethics Committee, Nirmal Hospital |
Approved |
| Panchshil Institutional Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee, |
Approved |
| Unity Hospital Ethics Committee Unity Hospital, Unity Trauma Center and ICU |
Approved |
| Yashoda Academy of Medical Education and Research, Yashoda Hospitals |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
placebo + standard-of-care
Initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through 52 weeks of the treatment period.
subcutaneous injection |
| Intervention |
Zetomipzomib |
-zetomipzomib 30 mg + standard-of-care
Initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through 52 weeks of the treatment period.
subcutaneous injection
-zetomipzomib 60 mg + standard-of-care Initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through 52 weeks of the treatment period
subcutaneous injection |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Body mass index of ≥ 18 kg/m2 (m square)
eGFR ≥ 30 mL/min/1.73 m2 (m square)
-Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test
-Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening.
-UPCR ≥1.0 (Class III/IV +/-V) or UPCR ≥2.0 (Class V)
-Adequate hematologic, hepatic, and renal function |
|
| ExclusionCriteria |
| Details |
1)Current or medical history of:
-Central nervous system manifestations of SLE
-Overlapping autoimmune condition that may affect study assessments/outcomes
-Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening
-Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions
-Solid organ transplant or planned transplant during study
-Malignancy of any type, with exceptions for non-melanoma skin cancers and certain cancers >5 years ago
2) Has received dialysis within the 52 - weeks prior to Screening
3)Positive test at Screening for HIV, hepatitis B/C
4) Known intolerance to MMF or equivalent and corticosteroids |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary efficacy endpoint is the proportion of patients achieving complete renal response (CRR) at Week 37 |
37 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Partial Renal Response (PRR) |
Week 37 |
Partial Renal Response (PRR)
Complete Renal Response (CRR) |
Week 53 |
Partial Renal Response (PRR)
Complete Renal Response (CRR) |
Week 25 |
|
|
Target Sample Size
|
Total Sample Size="279"
Sample Size from India="38"
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 2 |
Date of First Enrollment (India)
Modification(s)
|
08/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/11/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).
The study was terminated early. |