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Trial record 18 of 1164 for:    MYCOPHENOLIC ACID

Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS

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ClinicalTrials.gov Identifier: NCT01801280
Recruitment Status : Completed
First Posted : February 28, 2013
Results First Posted : September 9, 2016
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Klemens Budde, Charite University, Berlin, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Transplantation
Immunosuppression
Drug Interaction
Interventions Drug: Mycophenolate sodium
Drug: Pantoprazole
Drug: Mycophenolate mofetil
Enrollment 20
Recruitment Details Recruitment lastet between January 2012 - March 2013.
Pre-assignment Details  
Arm/Group Title Sequence A Sequence B Sequence C Sequence D
Hide Arm/Group Description
  1. st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
  2. nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
  3. rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  4. th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  1. st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
  2. nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  3. rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  4. th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
  1. st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  2. nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  3. rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
  4. th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
  1. st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  2. nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
  3. rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
  4. th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
Period Title: Period 1
Started 5 [1] 5 5 5
Completed 5 4 5 5
Not Completed 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
[1]
Each period lasted 10-14 weeks
Period Title: Period 2
Started 5 4 5 5
Completed 4 4 5 5
Not Completed 1 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0
Period Title: Period 3
Started 4 4 5 5
Completed 4 4 5 5
Not Completed 0 0 0 0
Period Title: Period 4
Started 4 4 5 5
Completed 4 4 4 5
Not Completed 0 0 1 0
Reason Not Completed
Protocol Violation             0             0             1             0
Arm/Group Title Sequence A Sequence B Sequence C Sequence D Total
Hide Arm/Group Description
  1. st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
  2. nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
  3. rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  4. th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  1. st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
  2. nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  3. rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  4. th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
  1. st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  2. nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  3. rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
  4. th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
  1. st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
  2. nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.
  3. rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.
  4. th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.
Total of all reporting groups
Overall Number of Baseline Participants 5 5 5 5 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  y
Number Analyzed 5 participants 5 participants 5 participants 5 participants 20 participants
59  (12) 42  (14) 33  (17) 43  (14) 44  (16)
[1]
Measure Description: Age at transplantation
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 5 participants 20 participants
Female
2
  40.0%
2
  40.0%
0
   0.0%
4
  80.0%
8
  40.0%
Male
3
  60.0%
3
  60.0%
5
 100.0%
1
  20.0%
12
  60.0%
Age at study enrollment  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 5 participants 5 participants 20 participants
63  (11) 46  (16) 44  (15) 51  (19) 51  (16)
1.Primary Outcome
Title Dose-normalized AUC of Mycophenolic Acid
Hide Description

Bioavailability (12h AUC) of mycophenolic acid in renal transplant patients after administration of MMF+/-PAN and EC-MPS+/-PAN

For evaluation of pharmacokinetic and pharmacodynamic parameters blood will be collected before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after drug intake.

Time Frame Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for PK/PD analysis will be collected. On the next day new treatment starts. There are 4 study visits at the study center. Duration will be approximately 12hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mycophenolate Mofetil (MMF) MMF+PAN EC-MPS EC-MPS + PAN
Hide Arm/Group Description:

Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.

Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.

Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.

Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.

Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.

Pantoprazole tablet (PAN) once a day in the morning for two weeks.

Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.

Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.

Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.

Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.

Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.

Pantoprazole tablet (PAN) once a day in the morning for two weeks.

Overall Number of Participants Analyzed 17 17 17 17
Mean (Standard Deviation)
Unit of Measure: mg*h/L
41  (18) 38  (18) 43  (19) 46  (18)
Time Frame Adverse event data were collected at every study visit. No follow up data.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mycophenolate Mofetil (MMF) MMF + PAN EC-MPS EC-MPS + PAN
Hide Arm/Group Description

Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.

Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.

Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.

Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.

Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.

Pantoprazole tablet (PAN) once a day in the morning for two weeks.

Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.

Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.

Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.

Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.

Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.

Pantoprazole tablet (PAN) once a day in the morning for two weeks.

All-Cause Mortality
Mycophenolate Mofetil (MMF) MMF + PAN EC-MPS EC-MPS + PAN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mycophenolate Mofetil (MMF) MMF + PAN EC-MPS EC-MPS + PAN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      1/18 (5.56%)      0/18 (0.00%)      0/18 (0.00%)    
Gastrointestinal disorders         
Noro virus infection *  1/19 (5.26%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
Renal and urinary disorders         
Urinary tract infection *  0/19 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Mycophenolate Mofetil (MMF) MMF + PAN EC-MPS EC-MPS + PAN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/19 (21.05%)      3/18 (16.67%)      2/18 (11.11%)      2/18 (11.11%)    
Immune system disorders         
Common cold *  4/19 (21.05%)  4 3/18 (16.67%)  3 2/18 (11.11%)  2 2/18 (11.11%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Olesja Rissling
Organization: Charité University Hospital - Department of Nephrology
Phone: +49 30 450 514 153
Responsible Party: Klemens Budde, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01801280     History of Changes
Other Study ID Numbers: CERL 080A DE 20 T
2010-021275-92 ( EudraCT Number )
First Submitted: February 13, 2013
First Posted: February 28, 2013
Results First Submitted: December 17, 2014
Results First Posted: September 9, 2016
Last Update Posted: February 21, 2019