Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Chronic Kidney Disease Clinical Trial

— DONATO  

Official title:

Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200784
• Other study ID #: 6520-9961-03
• Secondary ID: 2009-015821-34
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2010
• Last updated: January 16, 2012
• Start date: August 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: Medice Arzneimittel Pütter GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hemodialysis since 3 months or longer

• hemodialysis frequency 3 times weekly

• stable phosphate binder dose since one month at screening

• serum phosphate level < 2,42 mmol/l at screening

• serum phosphate level > 1,52 mmol/l after wash out phase

• stable treatment with vitamin D analogues since one month at screening

Exclusion Criteria:

• congestive heart failure

• acute bleeding complications

• acute myocardial infarction

• peptic ulcers

• serious liver damage

• poorly controlled diabetes

• severe visual impairment

• uncontrolled high blood pressure

• thrombocyte count < 120/nl

• difficulties in swallowing or dysphagia

• diminished intestinal motility, megacolon, pseudo- or mechanical obstruction

• gastroparesis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hemodialysis
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Nicotinamide
dosage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medice Arzneimittel Pütter GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum phosphate		4 weeks of active treatment	No
Secondary	serum phosphate		8 weeks of active treatment	No
Secondary	serum calcium		4 and 8 weeks of acitve treatment	No
Secondary	serum PTH		4 and 8 weeks of active treatment	No
Secondary	adverse events		12 weeks	Yes