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

NCT02378194 | Completed Phase 2

• 1 other identifier: HD-003
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Renal Failure

Keywords

in stage 3 or 4 steps

Outcome Measures

Primary Outcomes (2)

• serum creatinine rate inverse number's change

  up to 24 weeks

• GFR measurements (confirmed by the method MDRD via the value of sCr)

  up to 24 weeks

Other Outcomes (1)

• Number of Participants with Adverse Events

  up to 1 year

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

HD-003 (800mg/day)

EXPERIMENTAL

Drug: HD-003 (800mg/day)

HD-003 (1600mg/day)

EXPERIMENTAL

Drug: HD-003 (1600mg/day)

Interventions

Placebo DRUG

24 weeks, once daily oral administration

Placebo group

HD-003 (800mg/day) DRUG

24 weeks, once daily oral administration

HD-003 (800mg/day)

HD-003 (1600mg/day) DRUG

24 weeks, once daily oral administration

HD-003 (1600mg/day)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with chronic renal failure which subjected to conservation therapy.
• Patient has 15\~59mL/min/1.736m2 glomerular filtration rate.
• 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.
• 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
• Inpatient or outpatient
• Age: 20\~75, gender: both

You may not qualify if:

• Patient who start treatment drug or diet that maybe inhibit progress of renal failure within 3 months of the study start
• Diabetic patients with unstable blood sugar regulation.
• Patient did not have blood pressure control
• Patient taking the combination of prohibited substances
• Dialysis patient
• Patient with gout
• Patient who merged with a progressive muscular dystrophy, polymyositis, etc.
• Patients with symptoms of cerebral vascular disorders
• Women who are pregnant or breast-feeding
• Patient with infectious disease
• Patient with gastric ulcer
• Patients who has difficult diet, medication, etc.
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• 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

Sponsors & Collaborators

• Hyundai Pharmaceutical Co., LTD.: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Choi

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: March 4, 2015
• Study Start: January 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 16, 2017

Record last verified: 2015-02