the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

Study Overview
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Brief Summary
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To investigate the feasibility of calcium dobesilate in the treatment of microvascular injury provides new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

Detailed Description
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The deterioration of renal function is closely related to microvascular damage, calcium dobesilate is known as microcirculation protective agent, the investigators will further study its effect of non dialysis patients with chronic renal failure and explore the feasibility of calcium dobesilate in treatment of renal microvascular injury, the investigators will provide new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

Official Title
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the Effect of Calcium Dobesilate on Non Dialysis Patients With Chronic Renal Failure

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Drug: Calcium Dobesilate group
* Drug: Conventional Treatment group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enroll the non dialysis patients with chronic renal failure hospitalized in the Department of Nephrology of the Affiliated Hospital of Xuzhou Medical University. According to the glomerular filtration rate, the patients who were not required to be dialysate were at CKD3-5 (GFR between 10 and 59ml/min). Exclusion Criteria: Exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis. Eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium Dobesilate group<br>Calcium dobesilate group was treated with calcium dobesilate (500mg, tid , po), its conservative treatment was the same as that of the conventional treatment group | Drug: Calcium Dobesilate group<br>* Calcium dobesilate was used to treat patients with chronic renal failure on the basis of conventional treatment.<br>* Other names: Treatment group;|
| Placebo Comparator: Conventional Treatment group<br>conventional treatment group was treated with conventional conservative treatment of renal failure (low protein, low salt, low fat, low phosphorus diet, balance the internal environment; control blood pressure ; remove intestinal toxins etc.) | Drug: Conventional Treatment group<br>* Conventional treatment were used to treat patients with chronic renal failure.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glomerular filtration rate | emission computed tomography | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine | intravenous blood sampling | up to 6 months | 
| Cystatin C | intravenous blood sampling | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium Dobesilate, Non Dialysis Patients With CKD(3-5), Glomerular filtration rate, serum creatinine