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the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

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ClinicalTrials.gov Identifier: NCT03427944
Recruitment Status : Unknown
Verified January 2018 by The Affiliated Hospital of Xuzhou Medical University.
Recruitment status was:  Recruiting
First Posted : February 9, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of Xuzhou Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Drug: Calcium Dobesilate group Drug: Conventional Treatment group Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Effect of Calcium Dobesilate on Non Dialysis Patients With Chronic Renal Failure
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Drug: Calcium Dobesilate group
Calcium dobesilate was used to treat patients with chronic renal failure on the basis of conventional treatment.
Other Name: Treatment group
Placebo Comparator: 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.)
 Drug: Conventional Treatment group
Conventional treatment were used to treat patients with chronic renal failure.
Other Name: Control group


Outcome Measures
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Primary Outcome Measures :
  1. glomerular filtration rate [ Time Frame: up to 6 months ]
    emission computed tomography


Secondary Outcome Measures :
  1. serum creatinine [ Time Frame: up to 6 months ]
    intravenous blood sampling

  2. Cystatin C [ Time Frame: up to 6 months ]
    intravenous blood sampling


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427944


Contacts
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Contact: Dong Sun, MD 15862158578 sundong126@yahoo.com

Locations
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China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Dong Sun, MD    15862158578    sundong126@yahoo.com   
Sponsors and Collaborators
The Affiliated Hospital of Xuzhou Medical University
Investigators
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Study Director: Dong Sun, MD The Affiliated Hospital of Xuzhou Medical University
More Information
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Publications:

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Responsible Party: The Affiliated Hospital of Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03427944    
Other Study ID Numbers: XYFY2016-KL001-02
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The Affiliated Hospital of Xuzhou Medical University:
Calcium Dobesilate
Non Dialysis Patients With CKD(3-5)
Glomerular filtration rate
serum creatinine
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Calcium Dobesilate
 Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Hemostatics
Coagulants