Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Change From Baseline to Chronic Kidney Disease Patient Before and After Administration Drug

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378194
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Hyundai Pharmaceutical Co., LTD.

Brief Summary:

Chronic renal failure is a syndrome that renal function is decreased, and the patient number is increasing. In addition, patients on dialysis have also increased. Depending on the chronic renal failure aggravated, the deterioration of life caused by the conduct of dialysis patients is caused. In addition, a problem in dialysis treatment is ongoing economic burden surface to increase the life of the patient and family. A solution to this problem is, or stops the progression of chronic renal failure prior to dialysis, it is necessary to delay. As a treatment for inhibiting the progression of chronic renal failure is present, along with diet and blood pressure-lowering drugs or a drug therapy used by kremezin. However, the effect is not enough, new drug development is required.

HD-003 is a novel compound, and found to inhibit the renal failure progression. It was found during the search active substance that appear when the inflammation in animals. The investigators confirmed that the substance is present in the urine of a person during the study, and later established a link between kidney disease hypotheses. When performing the test in animal model renal failure, chronic renal Through the non-clinical testing of the HD-003(general toxicity studies, reproductive, developmental toxicity test, mutagenicity test and antigen tests) showed that a very low toxicity. When going through the review of the safety and pharmacokinetic Phase 1 clinical study, it was confirmed a very satisfactory safety and tolerability. And pharmacokinetic results from the body's absorption in healthy subjects had been done well, a linear correlation was observed. Finally, it was confirmed that the most rapidly excreted into the urine.

This study is a Phase 2a clinical trials performed in patients with chronic renal failure in 3, 4 steps. The evaluation of changes in serum creatinine(sCr) in vivo indicator of renal failure according to the progress. Evaluating the inhibitory effect of HD-003 renal failure progression and dose setting, and to determine the safety.


Condition or disease Intervention/treatment Phase
Chronic Renal Failure Drug: Placebo Drug: HD-003 (800mg/day) Drug: HD-003 (1600mg/day) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : January 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Placebo Comparator: Placebo group Drug: Placebo
24 weeks, once daily oral administration

Experimental: HD-003 (800mg/day) Drug: HD-003 (800mg/day)
24 weeks, once daily oral administration

Experimental: HD-003 (1600mg/day) Drug: HD-003 (1600mg/day)
24 weeks, once daily oral administration




Primary Outcome Measures :
  1. serum creatinine rate inverse number's change [ Time Frame: up to 24 weeks ]
  2. GFR measurements (confirmed by the method MDRD via the value of sCr) [ Time Frame: up to 24 weeks ]

Other Outcome Measures:
  1. Number of Participants with Adverse Events [ Time Frame: up to 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient diagnosed with chronic renal failure which subjected to conservation therapy.
  2. Patient has 15~59mL/min/1.736m2 glomerular filtration rate.
  3. Serum creatinine(sCr) is in the range of 1.5~5.0mg/dL at the start of the test and until the start of the test from 52 weeks the serum creatinine is three times more than the number of measurements, and during the final test values of serum creatinine patients with advanced value rises 0.2mg/dL or higher than the first tests.
  4. From the start of the test until 52 weeks before the test, serum creatinine the slope of the straight line for the inverse of the value is less than the rare patient -0.0001
  5. Inpatient or outpatient
  6. Age: 20~75, gender: both

Exclusion Criteria:

  1. Patient who start treatment drug or diet that maybe inhibit progress of renal failure within 3 months of the study start
  2. Diabetic patients with unstable blood sugar regulation.
  3. Patient did not have blood pressure control
  4. Patient taking the combination of prohibited substances
  5. Dialysis patient
  6. Patient with gout
  7. Patient who merged with a progressive muscular dystrophy, polymyositis, etc.
  8. Patients with symptoms of cerebral vascular disorders
  9. Women who are pregnant or breast-feeding
  10. Patient with infectious disease
  11. Patient with gastric ulcer
  12. Patients who has difficult diet, medication, etc.
  13. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  14. Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator

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): NCT02378194


Sponsors and Collaborators
Hyundai Pharmaceutical Co., LTD.
Investigators
Layout table for investigator information
Principal Investigator: Choi Yonsei University Health System, Severance Hospital
Layout table for additonal information
Responsible Party: Hyundai Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT02378194    
Other Study ID Numbers: HD-003
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: February 2015
Keywords provided by Hyundai Pharmaceutical Co., LTD.:
in stage 3 or 4 steps
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic