| CTRI Number |
CTRI/2020/12/030086 [Registered on: 29/12/2020] Trial Registered Prospectively |
| Last Modified On: |
28/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
RenoDiet-HP in Chronic Kidney Disease Patients Undergoing Maintenance Hemodialysis |
|
Scientific Title of Study
|
Safety and Efficacy of Oral Nutritional Supplement (RenoDiet-HP) in Patients with Chronic Kidney Disease Undergoing Maintenance Haemodialysis |
| Trial Acronym |
RenoDiet-HP in CKD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geeta Sheth |
| Designation |
Associate Professor, Department of Nephrology |
| Affiliation |
Sir Jamshedjee Jeejeebhoy Group of Hospital |
| Address |
Department of Nephrology
Sir Jamshedjee Jeejeebhoy Group of Hospital, Jamshedjee Jeejeebhoy Marg, Nagpada-Mumbai Central,
Off Jejeebhoy road,
Mumbai - 400 008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9870735192 |
| Fax |
|
| Email |
dr.geetasheth@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Sheth |
| Designation |
Associate Professor, Department of Nephrology |
| Affiliation |
Sir Jamshedjee Jeejeebhoy Group of Hospital |
| Address |
Department of Nephrology
Sir Jamshedjee Jeejeebhoy Group of Hospital,
J J Marg, Nagpada-Mumbai Central,
Off Jejeebhoy road,
Mumbai - 400 008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9870735192 |
| Fax |
|
| Email |
dr.geetasheth@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Sheth |
| Designation |
Associate Professor, Department of Nephrology |
| Affiliation |
Sir Jamshedjee Jeejeebhoy Group of Hospital |
| Address |
Department of Nephrology
Sir Jamshedjee Jeejeebhoy Group of Hospital,
J J Marg, Nagpada-Mumbai Central,
Off Jejeebhoy road,
Mumbai - 400 008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9870735192 |
| Fax |
|
| Email |
dr.geetasheth@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. Harsh Chaturvedi Associate Vice President, Medical Affairs,
Pulse Pharmaceuticals Pvt. Ltd.
Plot No. 18/1, Sector-III, HUDA Techno Enclave
Hi-Tech City, Madhapur, Hyderabad - 500 081 91009 56190/ 99201 30390 |
|
|
Primary Sponsor
|
| Name |
Pulse Pharmaceuticals Pvt Ltd |
| Address |
Plot No. 18/1, Sector-III, HUDA Techno Enclave Hi-Tech City, Madhapur, Hyderabad - 500 081 91009 56190/ 99201 30390 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Geeta Sheth |
Grant Medical College &Sir Jamshedjee Jeejeebhoy Group of Hospitals |
Department of Nephrology, J J Marg, Nagpada Mumbai Central, Noor Baug, Mazgaon, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA |
9870735192
dr.geetasheth@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AT GRANT GOVERNMENT MEDICAL COLLEGE & SIR J.J GROUP OF HOSPITALS |
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 |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
RENODIET-HP |
Oral Nutritional Supplement (RenoDiet-HP) 32g in 65ml of normal water twice daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All consenting patients with CKD, above 18 years of age, and receiving twice or thrice weekly maintenance hemodialysis for atleast 6 months at the outpatient hemodialysis unit will be included in the study.
2. Patients willing to sign the Informed Consent Form (ICF). |
|
| ExclusionCriteria |
| Details |
1. Patients with intercurrent acute illnesses.
2. Bodyweight less than 40 kg.
3. Documented history of dialysis non-compliance.
4. Documented malabsorption syndrome.
5. Contraindications to any ingredient of RenoDiet-HP.
6. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. (Chronic illness may include but is not limited to, cardiac, renal, autoimmune, hepatic, haematological, genetic disorders, atopic conditions, congenital defects, diabetes, convulsions or encephalopathy, tuberculosis etc.).
7. Pregnant & Lactating women.
8. Patients who are not willing to sign the ICF.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess any changes in the levels of serum albumin, haemoglobin, phosphorus, potassium, and total iron-binding capacity (TIBC), and body weight after treating with RenoDiet-HP for 03 months. |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Malnutrition Inflammation Score (MIS) & Subjective Global Assessment (SGA). |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included ctri.nic.in).
- For how long will this data be available start date provided 23-06-2021 and end date provided 22-06-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
- Reno Diet-HP is specially designed high calorie and high
protein nutrition for the dietary management of CKD. It provides high
biological value (HBV) protein and meets the nutrition demands of dialysis by
increasing the body stores of protein and energy fuel, thus mitigating the
effects of PEW.
- The aim of the present
study is to explore the safety and efficacy of
oral nutritional supplement (RenoDiet-HP) in patients with CKD undergoing
maintenance hemodialysis.
- The objective of the study is to assess any changes in the levels of
serum albumin, haemoglobin, phosphorus, potassium, and total iron-binding
capacity (TIBC), and body weight after treating with RenoDiet-HP for 03 months and txo assess the Malnutrition Inflammation
Score (MIS) & Subjective Global Assessment (SGA).
|