Study Details

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A study looking at kidney function in kidney transplant recipients who are taking anti-rejection medication including tacrolimus and with or without sirolimus.

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01363752

Astellas Study ID

The unique identification code given by the study sponsor.

PMR-EC-1212

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2010-019639-37

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Condition

Kidney Transplants

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Mar 2011 - Sep 2013

Masking

None (Open Label)

Enrollment number

853

A Multicenter, Two Arm, Randomized, Open Label Clinical Study Investigating Renal Function in an Advagraf® Based Immunosuppressive Regimen With or Without Sirolimus in Kidney Transplant Patients

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

1548

Leipzig, Germany, 04103

1140

Vienna, Austria, 1090

5343

Tainan, Taiwan, Province of China, 70403

3043

Istanbul, Turkey, 34245

3041

Antalya, Turkey, 07059

1141

Innsbruck, Austria, 6020

1545

Hann.Munden, Germany, 34346

1740

Brest Cedex 2, France, 29609

2641

Poznan, Poland, 60-479

5245

Busan, Republic of Korea, 614-735

1549

Munchen, Germany, 81377

Site 1441

Brno, Czech Republic, 656 91

1748

Tours cedex 9, France, 37044

1744

Caen cedex 9, France, 14033

1643

Santander, Spain, 39008

1547

Kiel, Germany, 24105

3042

Istanbul, Turkey, 07058

5244

Seoul, Republic of Korea, 138-736

2642

Warsaw, Poland, 02-006

5342

Taoyuan, Taiwan, Province of China, 33305

1240

Liege 1, Belgium, 4000

2144

Palermo, Italy, 90124

5042

New Lambton, Australia, NSW 2305

1546

Heidelberg, Germany, 69120

5241

Seoul, Republic of Korea, 120-752

2141

Bologna, Italy, 40138

3045

Istanbul, Turkey, 06490

1742

Clermont-Ferrand Cedex 1, France, 63003

1751

Toulouse Cedex 9, France, 31059

3240

Minsk, Belarus, 220116

3540

Vilnius, Lithuania, LT-08661

1142

Linz, Austria, 4020

1550

Munster, Germany, 48149

2640

Lodz, Poland, 91-153

3340

Tartu, Estonia, 51014

5243

Daegu, Republic of Korea, 700-721

2140

Siena, Italy, 53100

1542

Erlangen, Germany, 91054

1241

Leuven, Belgium, 3000

5441

Hong Kong, Hong Kong

1544

Frankfurt, Germany, 60596

1641

Barcelona, Spain, 08907

1749

Paris Cedex 15, France, 75743

1752

Amiens Cedex, France, 80054

2843

Moscow, Russian Federation, 115446

1745

Vandoeuvre Les Nancy Cedex, France, 54511

3044

Istanbul, Turkey, 34732

1543

Essen, Germany, 45147

5043

Perth, Australia, WA 6009

2643

Katowice, Poland, 40-027

2841

Kemerovo, Russian Federation, 650066

2440

Maastricht, Netherlands, 6229 HX

1746

Creteil Cedex, France, 94010

1741

Le Kremilin Bicetre Cedex, France, 94275

2842

Omsk, Russian Federation, 644112

5242

Seoul, Republic of Korea, 110-744

2840

Vol'ginskiy, Russian Federation, 404120

2142

Pisa, Italy, 56124

1642

Vizcaya, Spain, 48903

1640

Alicante, Spain, 03010

1541

Bochum, Germany, 44892

2143

Roma, Italy, 00168

1540

Hannover, Germany, 30625

1940

Budapest, Hungary, 1082

1743

Paris cedex, France, 75010

1440

Ostrava - Poruba, Czech Republic, 78 52

1750

Dijon, France, 21000

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