the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

February 12, 2018 updated by: The Affiliated Hospital of Xuzhou Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Investigators

  • Study Director: Dong Sun, MD, The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

February 3, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2016-KL001-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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