the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

Phase 4

• Conditions: Chronic Renal Failure
• Interventions: Drug: Calcium Dobesilate group; Drug: Conventional Treatment group

• Registration Number: NCT03427944
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2018-01
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-02-03
• Study First Posted: 2018-02-09
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-14
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium Dobesilate group	Calcium Dobesilate group	Calcium dobesilate group was treated with calcium dobesilate (500mg, tid , po), its conservative treatment was the same as that of the conventional treatment group
Conventional Treatment group	Conventional Treatment group	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.)

Primary Outcome Measures

Name	Time	Method
glomerular filtration rate	up to 6 months	emission computed tomography

Secondary Outcome Measures

Name	Time	Method
serum creatinine	up to 6 months	intravenous blood sampling
Cystatin C	up to 6 months	intravenous blood sampling

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China