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A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients

A

Alebund

Status and phase

Completed
Phase 2

Conditions

Hyperphosphatemia

Treatments

Drug: Sevelamer Carbonate
Drug: VS-505

Study type

Interventional

Funder types

Industry

Identifiers

NCT04551300
APCKD001

Details and patient eligibility

About

A multi-center, open-label, parallel-design, active-controlled phase 2 study to evaluate the tolerability, safety and efficacy of various dosages of VS-505 compared with Sevelamer Carbonate when given orally with meal for 6 weeks to treat hyperphosphatemia in chronic kidney disease subjects receiving maintenance hemodialysis.

Full description

The main body of this study has 5 intervention arms, 4 VS-505 treatment arms of various dosage plus 1 active control arm of Sevelamer Carbonate, each consists 25 subjects. Prior to this main part, a dose escalating cohort of 25 subjects is added to evaluate the tolerability of VS-505 in Chinese patient population.

Enrollment

158 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults with end stage renal disease who are receiving a stable hemodialysis regimen (3 times per week) with sufficient dialysis adequacy;
  • Serum phosphorus level range from >1.94 mmol/L (6.0 mg/dL) to ≤3.23 mmol/L (10.0 mg/dL) at the end of washout phase.

Exclusion criteria

  • Kidney transplant patient or scheduled kidney transplant, or change to peritoneal dialysis, home hemodialysis or plan to relocate to another dialysis center during the study period;
  • Serum phosphorus level is <1.29 mmol/L(4.0 mg/dL) or >2.42 mmol/L(7.5 mg/dL) at screening, or documented to be >3.23 mmol/L(10 mg/dL) within the latest three month prior to screening (screening included);
  • Serum calcium level is <8 mg/dL or >11 mg/dL at the screening;
  • Serum immunoreactive parathyroid hormone (iPTH)>1000 pg/mL at the screening;
  • History of hemochromatosis or serum ferritin value ≥1000 μg/L at screening;
  • Current clinically significant gastrointestinal (GI) disorder, or history of intestine obstruction, gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening;
  • Poorly controlled hypertension, cardiovascular disorders, and history of cerebrovascular disease or cardiovascular disease event within 24 weeks (6 months) prior to screening.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

158 participants in 5 patient groups

VS-505 500mg
Experimental group
Description:
VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg.
Treatment:
Drug: VS-505
VS-505 750mg
Experimental group
Description:
VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg.
Treatment:
Drug: VS-505
VS-505 1500mg
Experimental group
Description:
VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg.
Treatment:
Drug: VS-505
VS-505 2250mg
Experimental group
Description:
VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg.
Treatment:
Drug: VS-505
Sevelamer Carbonate 1600mg
Active Comparator group
Description:
Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.
Treatment:
Drug: Sevelamer Carbonate

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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