A clinical trial to evaluate the clinical effects on safety and efficacy of Kremezin® on suppression of progression of Chronic Renal Failure.

Phase 3

Completed

• Conditions: Health Condition 1: null- Chronic Kidney Disease stage 3 and 4

• Registration Number: CTRI/2010/091/000349
• Lead Sponsor: G Life Sciences India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 232

Inclusion Criteria

A. Outpatients only of either sex of 18-70 years

B. CKD Stage 3, 4 (GFR by Cockcroft Gault equation 15-59 mL/min 1.73M2)

C. Blood pressure that is well controlled during the observation period

D. Willing and able to give informed consent and comply with study procedures.

Exclusion Criteria

1. Received any investigational agent or participated in a clinical study with the previous 2 months
2. History of gastrointestinal disease (active gastric ulcer, inflammatory bowel diseases,hiatal hernia, active peptic ulcer, or severe GI dysmotility)
3. Obstructive urologic disease and other reversible kidney
diseases
4. Chronic kidney disease due to autosomal dominant polycystic kidney disease
5. Severe nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine (both components measured as mg/dl or other like units) of > 6.0 as measured on a spot void.
6. History of previous kidney transplant
7. History of recent (within the past 1 month) accelerated
or malignant hypertension
8. Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina or severe cardiac disease within the past 6 months
9. Liver cirrhosis
10. Patients with active infection, uncontrolled inflammatory disease
11. Progressive malignant disease
12. Cerebral infarction and intracranial hemorrhage within 6 months , except transient ischemic attack (TIA)
13. Uncontrolled blood sugar (HbA1c > 9%)
14. Severe anaemia, Hb <7 g/dL
15. ALT or AST > 2.5 times the upper limit of normal
Life expectancy less than 12 months at the point of Randomization
16. Received immunosuppressive therapy (including systemic
corticosteroids for more than 5days at a daily dose in excess of 0.1 mg/kg, prednisolone equivalent) in the past 3 months, or anticipated to require such treatment during the study course.Pregnant patients and willing to bear child during study. 17. Patient with marked changes in diseases status such as cases with abnormally high levels of blood pressure (diastolic pressure 120 mm Hg or over) or unstable levels,
18. Patients judged as inadequate subjects for the study by investigators such as those with markedly poor self-management.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement rating of the change of 1/ Cr (creatinine) with time in the two groups. The improvement ratings will be determined the ratio of greater than 1 as improved, the ratio equal to 1 as unchanged and the ratio lesser than 1 as aggravated.Timepoint: Observation period (-24 weeks) to treatment period (48 weeks)

Secondary Outcome Measures

Name	Time	Method
Improvement rating of uremic symptoms such as anorexia, halitosis, nausea and pruritis from baseline in the two groups, according to the 3 - Grade criteria viz. Improved, Unchanged and AggravatedTimepoint: 48 weeks