| CTRI Number |
CTRI/2025/04/084065 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of bioelectrical stimulation on Klotho protein in patients with Chronic Kidney Disease and healthy individuals |
|
Scientific Title of Study
|
Use of Bioelectric Stimulation (BES) to increase serum levels of circulating Klotho protein in patients with non-dialysis dependent chronic kidney disease (CKD) compared to health individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soumya Mishra |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Physiology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar
Department of Physiology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9583236596 |
| Fax |
|
| Email |
soumya.mishra@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Mishra |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Physiology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar
Department of Physiology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9583236596 |
| Fax |
|
| Email |
soumya.mishra@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Mishra |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Physiology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar
Department of Physiology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9583236596 |
| Fax |
|
| Email |
soumya.mishra@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Soumya Mishra |
| Address |
Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Manoja Kumar Das |
Director Projects, The INCLEN Trust International, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soumya Mishra |
KIMS |
Department of Physiology, Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar
Khordha
ORISSA |
9583236596
soumya.mishra@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health volunteers without renal disease |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (2) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healthy participants |
20 patients with CKD not on dialysis and 20 health individuals who shall be given BES therapy twice a week each session 45 minutes with simultaneous kidney and quadriceps stimulation |
| Intervention |
The BES shall be provided using the device Sys Stim 240 (Mettler Electronics Corp, CA), which has been certified for external application and neuromuscular usage |
20 patients with CKD not on dialysis and 20 health individuals who shall be given BES therapy twice a week each session 45 minutes with simultaneous kidney and quadriceps stimulation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 65 years
Any gender
CKD with Glomerular Filtration Rate (GFR) between 30-50 ml per min for more than 3 months
Able to read and understand the study protocol
Able to attend all 16 treatment sessions
No evidence of current infection on clinical assessment
Able to ambulate above 300 meters in 6 minutes |
|
| ExclusionCriteria |
| Details |
Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form
Intolerance to low level bioelectric stimulation and, or skin sensitivity change
History or clinical evidence of stroke in past 6 months with residual limitation to ambulation
Disabling musculoskeletal disease
Uncontrolled hypertension with Systolic blood pressure greater than 180 mmHg and diastolic blood pressure greater than 100 mmHg on two measurements
Grade III or IV heart failure according to NYHA or hospitalization for heart failure in past 3 months
Uncontrolled diabetes fasting blood glucose more than 250 mg per dL and HgbA1C greater than 10
Unstable angina
Coronary stent placement in past 3 months
Acute myocardial infarction within past three months
Presence of fever and, or any acute illness
Active smoker
Peripheral vascular disease in the lower limbs that limits ambulation less 300 meters or has rest pain
Chronic obstructive lung disease that limits ambulation or need for oxygen therapy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the serum Klotho protein level |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o Change in the renal function (BUN, serum creatinine) and GFR
o Change in the systolic and diastolic blood pressures
o Change in the 6 minute walk test performance
o Change in Quality of Life status, as assessed by the questionnaire Kidney Disease and Quality-of-Life Short-F3rm (KDQOL-SFTM).
o Tolerance and safety of BES therapy
o Compliance to the BES therapy sessions |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/05/2025 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Background:
Chronic kidney
disease (CKD) patients have limited options for management and most progress
over time to end stage renal disease (ESRD) requiring renal replacement therapy
(haemodialysis) and/or renal transplantation. There is need to find alternative
therapeutic and/or stabilisation options for the CKD patients to avoid the
inevitable progression to ESRD. Klotho protein,
is primarily produced in the kidney and serum levels are directly correlated
with the renal function. Several animal models have proposed potential
improvement and/or delay in deterioration of the renal function. Precise
micro-current levels of bioelectric stimulation (BES) has been associated with
a significant upregulation of constitutive pro-regenerative target proteins in
various tissues. Hypothesis: The BES applied to kidney and quadrÃceps muscle
shall increase the in circulating serum Klotho protein as a proxy marker of
renal tissue regeneration in the CKD patients not on dialysis compared to the
healthy participants.
Participants: We shall recruit 40 participants; 20 patients with CKD not on
dialysis and 20 healthy individuals who shall be given BES therapy twice a week
(each session 45 minutes with simultaneous kidney and quadriceps stimulation).
Data
collection: The participants shall be assessed at baseline and
endline (after 8 weeks of BES therapy) including the physical examination,
blood pressure, ECG, blood parameters (complete blood count, RFT, LFT, blood
sugar), urine 24 hour protein and serum klotho protein.
Outcomes: The study shall document the changes in serum klotho protein between the
baseline and endline (after 8 weeks therapy) along with the renal function (GFR
and sérum creatinine), blood pressure, 6 minute walk test performance, Quality of Life and any adverse
events with the BES therapy. |