| CTRI Number |
CTRI/2024/11/076264 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [TREATMENT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on effect of metabolic acidosis correction on progression of CKD |
|
Scientific Title of Study
|
Effect of correction of metabolic acidosis on CKD progression – A randomised controlled trial
|
| 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 Priyamvada PS |
| Designation |
PROFESSOR |
| Affiliation |
jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Nephrology
JIPMER Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598566984 |
| Fax |
|
| Email |
priyamvadaps@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathy Raju |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
DEPARTMENT OF NEPHROLOGY
JIPMER PUDUCHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9447753585 |
| Fax |
|
| Email |
swathiraju7777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathy Raju |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
DEPARTMENT OF NEPHROLOGY
JIPMER PUDUCHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9447753585 |
| Fax |
|
| Email |
swathiraju7777@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research (JIPMER),Dhanvantari Nagar,Puducherry, India PIN-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of postgraduate medical education and research |
| Address |
Dhanvantari Nagar, Puducherry, India
PIN-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyamvada PS |
Jawaharlal institute of postgraduate medical education and research |
Outpatient clinic ,DEPARTMENT OF NEPHROLOGY Room 5204,2nd floor ,super specialty block
JIPMER
Pondicherry
PONDICHERRY |
7598566984
priyamvadaps@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE JIPMER |
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 |
Standard of care treatment (SOC) for CKD |
Only standard of care for the treatment of CKD will be given |
| Intervention |
Standard of care for CKD and Sodium Bicarbonate tablets |
The intervention arm will receive the standard of care for CKD and generic sodium Bicarbonate 500mg tablet containing 6mEq of bicarbonate. The starting dose of the sodium bicarbonate will be standardised according to the baseline venous bicarbonate level of the patient. If the initial bicarbonate level is between 18 to 20meq/l , 4 tablets will be given and if the level is between 20 to 22 meq/l, 3 tablets will be given. The frequency will be either BD ,TID or QID according to the number of tablets. Venous bicarbonate levels will be monitored monthly and sodium bicarbonate dosage will be titrated accordingly to maintain a venous bicarbonate level in the range of 24 to 28 mEq /l and that dose which is required to maintain this level of 24-28meq/l will be continued till the end of the study. The total follow up duration is 6 months. Due to the concern of sodium load, the maximum permissible number of sodium bicarbonate tablets will be 16 (96 mEq of sodium bicarbonate) ,that is 4 tablets QID.
The total duration of intervention is 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Chronic kidney disease stage 3 and 4.
2.Venous bicarbonate levels 18-22 mEq/L documented on 2 occasions 1 month apart
3.should not have received bicarbonate supplementation for a period of 4 weeks prior to recruitment
4.documented stable eGFR, less than 5 percentage change in the preceding 3 months
|
|
| ExclusionCriteria |
| Details |
1.Symptomatic Hypocalcemia
2.Patients being considered for elective renal replacement in the subsequent six months
3.Patients with any significant comorbidities limiting life expectancy
4.Nephrotic range proteinuria
5.Decompensated heart failure with New York heart association (NYHA) class 3 or 4 symptoms
5.Decompensated chronic liver disease
6.Pregnancy
7.Persistent volume overload despite optimal diuretic therapy
8.Kidney transplant
9.Use of immunosuppression
10.A recent history of acute kidney injury (according to the KDIGO criteria) in the preceding three months, prior to recruitment
11.Respiratory disorders associated with hypercapnia
12.serum potassium less than 3 or more than 5.5 milliequivalent per litre.
13.serum bicarbonate less than 18 meq per litre
14.Uncontrolled hypertension as defined by BP more than SBP 160 and DBP 90 on maximal dosage of three antihypertensives and one diuretic |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of metabolic acidosis correction on eGFR in patients with CKD stage 3 and 4
2.To assess the effect of Metabolic acidosis correction on urine albumin creatinine ratio in patients with CKD stage 3 & 4
|
0 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of MA correction on dietary acid load(Net endogenous acid production, potential renal acid load and urine net acid excretion )in patients with CKD stage 3 & 4
|
0 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study aims to compare the effects of correcting metabolic acidosis to achieve venous bicarbonate levels of 24 to 28 meq/L in patients with chronic kidney disease (CKD) versus standard care alone. Previous research from our center has not shown clear benefits, largely because many patients were unable to reach these bicarbonate levels, particularly those with severe metabolic acidosis.
To address this, the current trial will include early-stage CKD patients. It is expected to generate data on two important outcomes related to metabolic acidosis : albuminuria and eGFR decline. The findings will provide evidence on the effect of alkali supplementation on CKD progression and offer insights into dietary acid load, potentially leading to personalized bicarbonate prescriptions based on net endogenous acid production (NEAP). All patients attending the Nephrology OPD will be screened for recruitment in to the study based on the inclusion and exclusion criteria. For eligible patients who were already on bicarbonate supplementation, the same will be stopped one month prior to the randomization and venous bicarbonate levels will be assessed . All consenting participants will be randomized to SOC vs SOC + bicarbonate supplementation for 6 months. All patients will be given dietary counselling before randomisation. Generic tablets of sodium bicarbonate containing 500 mg of sodium bicarbonate (6 mEq) will be used. Patients would be instructed to take the tablets 1 h after food to reduce the gastrointestinal side effects. Co-prescription of calcium carbonate will be avoided as CaCO3 being a potential source of bicarbonate. The compliance to medication will be checked by a social worker by assessing pill counts on monthly follow-up visits as well as by telephone calls. Taking more than 80% of prescribed medications will be considered as compliance with therapy. Due to the concern of sodium load, the maximum permissible number of sodium bicarbonate tablets will be 16 (96 mEq of sodium bicarbonate). The starting dose of sodium bicarbonate will be standardised depending on the venous bicarbonate level.
|