Trial · NCT00121810

Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients

NCT00121810, Phase 4, Completed, Hoffmann-La Roche; results first posted 2011-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients. Trials, record NCT00121810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00121810

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
NCT number: NCT00121810
Status: Completed
Phases: Phase 4
Enrollment: 305 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Kidney Transplantation
Interventions: mycophenolate mofetil [CellCept], Corticosteroids, Calcineurin inhibitors, Sirolimus
First posted: 2005-07-21
Last updated: 2011-04-15
Results first posted: 2011-02-24

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12	baseline to 12 months	The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= \[(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline\]\*100 percent.
Secondary	Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24	Baseline to 24 months	A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= \[(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline\]\*100 percent.
Secondary	Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24	baseline, 6, 12, and 24 months	Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization. percent change= \[(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline\]\*100 percent, where t=6, 12, and 24 months postrandomization.
Secondary	Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24	baseline 6, 12, and 24 months	Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization. percent change= \[(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline\]\*100 percent, where t=6, 12, and 24 months postrandomization
Secondary	Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)	baseline, 6, 12, and 24 months	Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization. percent change= \[(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline\]\*100 percent, where t=6, 12, and 24 months postrandomization.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12	baseline to 12 months	Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 12: MMF+sirolimus = 120, MMF+CNI = 111.	percent change	MEAN
SECONDARY	Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24	Baseline to 24 months	Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 24: MMF+sirolimus = 115, MMF+CNI = 105.	percent change	MEAN
SECONDARY	Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24	baseline, 6, 12, and 24 months	Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.	percent change	MEAN
SECONDARY	Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24	baseline 6, 12, and 24 months	Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 129; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.	percent change	MEAN
SECONDARY	Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)	baseline, 6, 12, and 24 months	Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 123, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.	percent change	MEAN

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12	Mycophenolate Mofetil + Sirolimus	Baseline	59.5	Standard Deviation 23.86	percent change
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Baseline	58.8	Standard Deviation 26.06	percent change
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12	Mycophenolate Mofetil + Sirolimus	Mean Percent Change from Baseline at Month 12	24.4	Standard Deviation 70.00	percent change
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mean Percent Change from Baseline at Month 12	5.2	Standard Deviation 56.33	percent change
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24	Mycophenolate Mofetil + Sirolimus	Baseline	59.5	Standard Deviation 23.86	percent change
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Baseline	58.8	Standard Deviation 26.06	percent change
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24	Mycophenolate Mofetil + Sirolimus	Percent Change from Baseline at Month 24	8.6	Standard Deviation 55.32	percent change
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Percent Change from Baseline at Month 24	3.4	Standard Deviation 67.28	percent change
Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24	Mycophenolate Mofetil + Sirolimus	Baseline	121.1	Standard Deviation 29.96	percent change
Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Baseline	124.4	Standard Deviation 37.87	percent change

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mycophenolate Mofetil + Sirolimus	151
Overall Study	STARTED	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	154
Overall Study	Safety Population	Mycophenolate Mofetil + Sirolimus	148
Overall Study	Safety Population	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	153
Overall Study	Intent-to-Treat (ITT) Population	Mycophenolate Mofetil + Sirolimus	148
Overall Study	Intent-to-Treat (ITT) Population	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	151
Overall Study	COMPLETED	Mycophenolate Mofetil + Sirolimus	121
Overall Study	COMPLETED	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	115
Overall Study	NOT COMPLETED	Mycophenolate Mofetil + Sirolimus	30
Overall Study	NOT COMPLETED	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	39

Source ClinicalTrials.gov

Adverse events384

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Urinary Tract Infection	Infections and infestations	Mycophenolate Mofetil + Sirolimus	22	148
other	Urinary Tract Infection	Infections and infestations	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	33	153
other	Upper Respiratory Tract Infection	Infections and infestations	Mycophenolate Mofetil + Sirolimus	21	148
other	Upper Respiratory Tract Infection	Infections and infestations	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	19	153
other	Nasopharyngitis	Infections and infestations	Mycophenolate Mofetil + Sirolimus	13	148
other	Nasopharyngitis	Infections and infestations	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	16	153
other	Pneumonia	Infections and infestations	Mycophenolate Mofetil + Sirolimus	14	148
other	Pneumonia	Infections and infestations	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	12	153
other	BK Virus Infection	Infections and infestations	Mycophenolate Mofetil + Sirolimus	0	148
other	BK Virus Infection	Infections and infestations	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	9	153

1 to 10 of 384Source ClinicalTrials.gov

See all 384 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mycophenolate Mofetil + Sirolimus
Total, all-cause mortality	Mycophenolate Mofetil + Cyclosporine or Tacrolimus
Total, other adverse events	Mycophenolate Mofetil + Sirolimus	147	148
Total, other adverse events	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	148	153
Total, serious adverse events	Mycophenolate Mofetil + Sirolimus	60	148
Total, serious adverse events	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	64	153

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Mycophenolate Mofetil + Sirolimus vs Mycophenolate Mofetil + Cyclosporine or Tacrolimus: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00121810

GET https://conductscience.org/api/trials/v1/NCT00121810/results?page=2

API reference For AI assistants