DONATO: Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Sponsor

Medice Arzneimittel Pütter GmbH & Co KG (Industry)

Overall Status

Completed

CT.gov ID

NCT01200784

Collaborator

(none)

252

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Hemodialysis Hyperphosphatemia	Drug: Nicotinamide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 250 mg/d modified release Nicotinamide	Drug: Nicotinamide dosage
Experimental: 500 mg/d modified release Nicotinamide	Drug: Nicotinamide dosage
Experimental: 750 mg/d modified release Nicotinamide	Drug: Nicotinamide dosage
Experimental: 1000 mg/d modified release Nicotinamide	Drug: Nicotinamide dosage
Active Comparator: 1000 mg/d immidiate release Nicotinamide	Drug: Nicotinamide dosage

Outcome Measures

Primary Outcome Measures

serum phosphate [4 weeks of active treatment]

Secondary Outcome Measures

serum phosphate [8 weeks of active treatment]
serum calcium [4 and 8 weeks of acitve treatment]
serum PTH [4 and 8 weeks of active treatment]
adverse events [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	Country	Postal Code
1	Alsfeld	Germany	36304
2	Arnstadt	Germany	99310
3	Augsburg	Germany	86157
4	Berlin Hellersdorf	Germany	12627
5	Berlin Kreuzberg	Germany	10245
6	Berlin	Germany	12045
7	Berlin	Germany	12203
8	Berlin	Germany	12435
9	Berlin	Germany	13051
10	Bielefeld	Germany	33602
11	Coburg	Germany	96450
12	Darmstadt	Germany	64295
13	Dortmund	Germany	44135
14	Dülmen	Germany	48249
15	Düsseldorf	Germany	40210
16	Elsenfeld	Germany	63820
17	Erfurt	Germany	99089
18	Essen	Germany	45127
19	Friedrichsroda	Germany	99894
20	Hamburg	Germany	22297
21	Hameln	Germany	31787
22	Herne	Germany	44623
23	Herzberg	Germany	04916
24	Iserlohn	Germany	58638
25	Jena-Drakendorf	Germany	07751
26	Kamen	Germany	59174
27	Leverkusen	Germany	51373
28	Mannheim	Germany	68309
29	Minden	Germany	32429
30	Nordhausen	Germany	99734
31	Osnabrueck	Germany	49074
32	Pfarrkirchen	Germany	84347
33	Regensburg	Germany	93053
34	Schwabach	Germany	91126
35	Tangermünde	Germany	39590
36	Wuppertal	Germany	42283