| CTRI Number |
CTRI/2024/07/071759 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non interventional study |
| Study Design |
Other |
|
Public Title of Study
|
Study to Identify and check Patients with Chronic Kidney Disease and Proteinuria |
|
Scientific Title of Study
|
A Study to Identify and Characterise Patients with Chronic Kidney Disease and Proteinuria |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D4325C00007 V1.0 06 Apr 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tapankumar M Shah |
| Designation |
Senior Director, Cluster Head, SMM BioPharmaceuticals, R&D BioPharmaceuticals, |
| Affiliation |
AstraZeneca Pharma India Ltd, |
| Address |
Block N1, 12th Floor, Manyata Embassy Business Park
Bangalore
KARNATAKA
560045
India |
| Phone |
9535104975 |
| Fax |
|
| Email |
tapankumar.shah@astrazeneca.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tapankumar M Shah |
| Designation |
Senior Director, Cluster Head, SMM BioPharmaceuticals, R&D BioPharmaceuticals, |
| Affiliation |
AstraZeneca Pharma India Ltd, |
| Address |
Block N1, 12th Floor, Manyata Embassy Business Park
Bangalore
KARNATAKA
560045
India |
| Phone |
9535104975 |
| Fax |
|
| Email |
tapankumar.shah@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Tapankumar M Shah |
| Designation |
Senior Director, Cluster Head, SMM BioPharmaceuticals, R&D BioPharmaceuticals, |
| Affiliation |
AstraZeneca Pharma India Ltd, |
| Address |
Block N1, 12th Floor, Manyata Embassy Business Park
Bangalore
KARNATAKA
560045
India |
| Phone |
9535104975 |
| Fax |
|
| Email |
tapankumar.shah@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca AB, 151 85 Södertälje, Sweden |
|
|
Primary Sponsor
|
| Name |
AstraZeneca AB |
| Address |
SE-151 85 Södertälje, Sweden |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AstraZeneca Pharma India Ltd |
Block N1, 12th Floor, Manyata Embassy Business Park,
Rachenahalli, Outer Ring Road, Bangalore - 560045,
Karnataka, India
|
|
|
Countries of Recruitment
|
Argentina
Brazil
Canada
China
India
Mexico
Philippines
Poland
Slovakia
South Africa
Sweden
Taiwan
Thailand
Turkey
United States of America
Viet Nam |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Kumar BT |
BGS Gleneagles Global Hospitals |
Department of Nephrology,
No. 67, Uttarahalli Main Road, Kengeri, PIN- 560060
Bangalore
KARNATAKA |
9916950554
anilbuskal@yahoo.co.in |
| Dr Ritesh Ramesh Vernekar |
KLES Dr Prabhakar Kore Hospital & Medical Research Centre |
Department of Nephrology, Nehrunagar, PIN- 590010
Bangalore
KARNATAKA |
9449061633
riteshvernekar@gmail.com |
| Dr Dinesh Khullar |
Max Super Speciality Hospital, Saket (West Block) |
(A unit of Max Healthcare Institute Limited) Department of Nephrology, M , 1 Press Enclave Road, Saket, PIN - 110017
New Delhi
DELHI |
9810124066
drdineshkhullar@gmail.com |
| Dr Hardik Baldevbhai Patel |
Muljibhai Patel Urological Hospital (MPUH) |
Department of Nephrology, C/o, Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, Nadiad, PIN- 387001
Navsari
GUJARAT |
9909103658
hrdik_patel@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee, Muljibhai Patel Society for Research in Nephro-Urology |
Approved |
| Institutional Ethics Committee, BGS Global Hospitals |
Submittted/Under Review |
| Institutional Ethics Committee, KLE University, KLE Dr.PK Hospital and MRC |
Approved |
| Max Healthcare Ethics Committee ,Saket |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOT APPLICABLE as Non randomized, Non interventional study |
NOT APPLICABLE as Non randomized, Non interventional study |
| Comparator Agent |
NOT APPLICABLE as Non randomized, Non interventional study |
NOT APPLICABLE as Non randomized, Non interventional study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Male or female aged greater than or equal to 18 years at the time of signing the informed consent
2 Express interest to participate in a future CKD clinical study
3 eGFR greater than or equal to 20 to less than 90 mL/ min/ 1.73 m square (eGFRcr[AS], Section 8.2.1) (Delgado et al 2022, Inker et al. 2021)
4 UACR greater than or equal to 700 mg/g or UPCR greater than or equal to 1000 mg/g based on urine sample at time of screening visit
5 Receiving RAS inhibitor therapy (ACEi or ARB) that has been at stable dosing for at least 4 weeks. Exceptions from this requirement will be made for participants who are unable to tolerate RAS inhibitor therapy
6 Provision of signed and dated written informed consent before any study-specific procedures
|
|
| ExclusionCriteria |
| Details |
1 Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
2 As per investigator judgement, patients who are not suitable and/or stable enough to participate in a phase 3 interventional study (eg, recent hospitalisation for HF, recent cardiac surgery or intervention, heart disease including stroke, life expectancy less than 2 years due to conditions other than renal or CV conditions, unable to commit for personal reasons to a phase 3 trial for up to 4 years)
3 Known T1DM
4 Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal)
5 Known history of solid organ transplantation
6 Known history or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin) or endothelin receptor antagonists (eg, ambrisentan, atrasentan, bosentan)
7 Known blood-borne diseases such as specified in Appendix B (category A and B)
8 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
9 Inability of the patient, in the opinion of the investigator, to understand and/or comply procedures and/or follow-up or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
10 Known pregnancy at the time for the visit or have an intention to become pregnant
11 Lupus nephritis, anti-neutrophil cytoplasmic autoantibody vasculitis, minimal change disease, autosomal dominant polycystic kidney disease (polycystic kidney disease), Alport syndrome, patients on renal replacement therapy, or clinical nephrotic syndrome with problematic oedema
12 Unable to commit for personal reasons to a phase 3 clinical trial of up to 4 years duration
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify and characterise patients with CKD and high proteinuria. Below parameters are assessed.
Age
Sex
T2DM (Y/N)
HF + NYHA class (if known)
ACEi (Y/N)
ARB (Y/N)
SGLT2i (Y/N)
CKD aetiology
eGFR
UACR
UPCR |
Summary statistics assessed at one single visit (at visit 1 which is one day)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To obtain an overview on current medication for patients with CKD & high proteinuria across different geographical regions |
Summary statistics assessed at one single visit (at visit 1 which is one day) |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="60"
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)
|
10/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/07/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The purpose of the D4325C00007 study is to identify and characterise patients with known or newly diagnosed CKD for possible participation in future renal clinical studies and to obtain an overview on current treatment choices for this patient group in different regions. This non- interventional study will aim to identify patients fulfilling the following eGFR and UACR criteria: eGFR ≥ 20 to < 90 mL/min/1.73 m2 UACR ≥ 700 mg/g or UPCR ≥ 1000 mg/g Low eGFR and proteinuria are key markers of kidney disease and results will be shared with the patient and their treating physician. |