Status:
COMPLETED
Controlled Study to Evaluate Efficacy and Safety of α-KA Tab With Low Protein Diet (LPD) in Delaying the Progress of Type 2 Diabetic Nephropathy (DN)
Lead Sponsor:
Fresenius Kabi
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Current expert opinion based consensus guidelines recommend usage of α-Keto analogues of essential amino acids in the diet of diabetic nephropathy patients, along with restricted protein diets. This s...
Detailed Description
Diabetic nephropathy is the most common cause for end-stage renal disease (ESRD) in Europe and America, which is directly related to rising incidence of type 2 diabetes. In addition, life lengthening ...
Eligibility Criteria
Inclusion
- Age \< 75 years, regardless of sex;
- Final diagnosis of type 2 diabetes;
- Plasma glucose is under control (fasting plasma glucose\<10mmol/L, glycosylated hemoglobin\<8.0%) with oral glucose-lowering agents (confine to Repaglinide, α-glycosidase inhibitors, Gliquidone) and /or insulin;
- Even through RAS blocker (ACEI/ARB) is administrated at a fixed dose (the same as the starting dose, refer to appendix 4) for more than 6 weeks, blood pressure is still ≤ 160/90 mmHg;
- Patient is without dialysis and GFR is \<60ml/min/1.73m2;
- Overt proteinuria is present two times within 2 weeks (urine albumin \> 300mg/d in a 24-h collection)
Exclusion
- Diabetic ketoacidosis within the last 6 months;
- Incapable of following study requirements to control diet;
- Glomerular filtration rate \< 15 ml/min/1.73m2;
- Hypercalcemia or hyperkalemia (\> normal upper limit);
- Other serious disease within the last 3 months;
- With obvious symptoms or signs of liver diseases, ALT or AST \> two times normal upper limit;
- Severe edema or serous cavity effusion;
- Drug abuse
- Final diagnosis of malignant tumor;
- Receiving the long-term systematic steroid hormone treatment;
- Gestation already, prepares to be pregnant in the period of the trial, lactating women;
- Participate in other product clinical trial within 30 days prior to this trial.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00363987
Start Date
May 1 2006
End Date
June 1 2009
Last Update
September 2 2010
Active Locations (1)
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1
Shanghai Huashan Hospital
Shanghai, China, 200040