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: Chronic Kidney Disease stage 3 and 4

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

Brief Summary

This clinical study is a randomised, parallel,active controlled, open label,phase III multicenter trial evaluating the safety and efficacy of Kremezin® upon administration of 6gm/ day alongwith the standard care of therapy for 48 weeks on 232 subjects with progression of chronic kidney disease of stage 3 and 4.The primary outcome measures Improvement rating of the change of 1/ Cr (creatinine) with time period from screenng to the end of treatment schedule in the two groups. The improvement rating of uremic symptoms such as anorexia, halitosis, nausea and pruritis from baseline in the two groups,from the period of screening to end of treatment schedule, according to the 3 - Grade criteria viz. Improved, Unchanged and Aggravated.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-11
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

• 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

• Received any investigational agent or participated in a clinical study with the previous 2 months2.
• 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 diseases4.
• Chronic kidney disease due to autosomal dominant polycystic kidney disease5.
• 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 transplant7.
• History of recent (within the past 1 month) accelerated or malignant hypertension8.
• Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina or severe cardiac disease within the past 6 months9.
• Liver cirrhosis10.
• Progressive malignant disease12.
• 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/dL15.
• ALT or AST > 2.5 times the upper limit of normal Life expectancy less than 12 months at the point of Randomization16.
• 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.
• 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.	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 Aggravated	48 weeks

Trial Locations

Locations (16)

9/5, Manoramaganj,; 🇮🇳 Indore, MADHYA PRADESH, India

Ajanta Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

All India Institute of Medical Sciences,; 🇮🇳 Delhi, DELHI, India

Apollo hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Bombay Hospital; 🇮🇳 Indore, MADHYA PRADESH, India

Care Hospital,; 🇮🇳 Nagpur, MAHARASHTRA, India

CHL Apollo Hospitals; 🇮🇳 Indore, MADHYA PRADESH, India

Columbia Asia Referral Hospital Yeshwantpur; 🇮🇳 Bangalore, KARNATAKA, India

Dayanand Medical College & Hospital; 🇮🇳 Ludhiana, PUNJAB, India

M.V. Hospital & Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

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9/5, Manoramaganj,

🇮🇳Indore, MADHYA PRADESH, India

Dr. Pradeep Salgia

Principal investigator

psalgia@sancharnet.in