Kidney TransplantationPhase 4OPTIMAIINCT00905515

Optima: Optimizing Prograf Therapy in Maintenance Allografts II

A Phase 4 study testing cyclosporine and Prograf (Tacrolimus) in people with Kidney Transplantation, run by East Carolina University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to optimize calcineurin immunosuppressive regimens and evaluate immunological and non-immunological markers that may explain mechanistic differences in these agents and their effects. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Kidney Transplantation
What is being tested?: cyclosporine and Prograf (Tacrolimus)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: Aug 2003to Jul 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is the recipient of a cadervic or living donor renal transplant.
Patient was 18 years of age at time of transplant.
Patient is at least 6 months post-transplant.
Patient has been on a cyclosporine-based immunosuppressive regimen since the transplant.
Patient has a functioning allograft and a Cockcroft/Gault estimate of creatinine clearance >or= 35 mL/min within four weeks prior to randomization.
Patient or legal guardian has signed and dated an Institutional Review Board (IRB) approved informed consent document and is willing and able to follow study procedures.
Females are not pregnant and agree to practice effective birth control while receiving immunosuppressant medication.

Who cannot join

Patient is the recipient of a solid organ transplant other than the kidney.
Patient experienced biopsy-confirmed, acute rejection, (Banff 97 criteria)within 3 months before randomization that required treatment, which is defined as antilymphocyte therapy, corticosteroids, or an increase in the number or dose of immunosuppressant medication.
Patient has recurrence of primary renal disease, or de novo renal disease.
Patient has a urine protein of > 1.5g/24 hours or two successive urinalyses sent to and reported by the laboratory indicating albuminuria greater than 2+ within 6 months prior to enrollment.
Patient has an estimated creatinine clearance < 35 mL/min calculated using Cockcroft/Gault formula within four weeks prior to randomization.
Patient has changed adjunctive immunosuppressant therapy within one month if randomization.

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Patient is pregnant or lactating.
Patient is a known carrier of any of the HIV viruses.
Patient has a known or suspected malignancy (except for treated squamous or basal cell skin cancers) < 5 years before randomization or a history of post-transplant lymphoproliferative disease (PTLD).
Patient has a known hypersensitivity to tacrolimus, or any of the excipients of the drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834

Other trials in United States

About this study

Read the detailed description

One of the major challenges in transplantation over the past two decades has been managing long-term renal function. Serum creatinine is the most commonly used serum marker of renal function. However serum creatinine is insensitive for detecting small decreases in glomerular filtration rate (GFR). Another marker for renal function is cystatin C. Dharnidharka et al concluded that cystatin C is superior to serum creatinine as a marker of kidney function since cystatin C was a more sensitive marker than serum creatinine for detecting decreases in GFR. Pirsch et al reported that tacrolimus-treated patients had a lower incidence of severe acute rejection and better lipid profiles than cyclosporine-treated patients.

Cardiovascular disease is the primary cause of premature death in renal and other transplant recipients. Current immunosuppressive protocols often elevate cardiovascular disease risk factors such as hypertension, hyperlipidemia, obesity and diabetes.

This study is designed to optimize calcineurin immunosuppressive regimens to ensure the best possible long-term outcomes after renal transplantation.

Conditions: Kidney Transplantation
Being tested: cyclosporine, Prograf (Tacrolimus)
Keywords: Kidney Transplantation, Immunosuppressive Agents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cyclosporineDrug
Also called Cyclosporine/Neoral®/Sandimmune®/Gengraf®
Maintain on cyclosporine at target trough level of 50-250 ng/mL.
Prograf (Tacrolimus)Drug
Also called Tacrolimus/Prograf®/FK506
Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).

Study groups in NCT00905515
Study group	Role	What they receive
Control Group Cyclosporine	Active comparator	Maintain on Cyclosporine (CsA) at target trough level of 50-250 ng/mL. Receives: Drug: cyclosporine
Low Trough Level Prograf Group	Active comparator	Convert to Prograf (TAC) at target trough levels of 3.0-5.9 ng/mL. Receives: Drug: Prograf (Tacrolimus)
High Trough Level Prograf Group	Active comparator	Convert to TAC at target trough levels of 6.0-8.9 ng/mL. Receives: Drug: Prograf (Tacrolimus)

What is being measured

The primary outcome is the main question the study is designed to answer.

Renal Function in Patients Converted From Cyclosporine to Prograf
Measured: 3 years
Optimal Dose of Calcineurin Inhibitor in Long-term Maintenance Kidney Transplant Patients
Measured: 3 years
Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2003Jul 2008

First posted20 May 2009 (estimated)
Study startAug 2003
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Kidney TransplantationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00905515
Sponsor's protocol ID: MR-06-001
Acronym: OPTIMAII
Status last verified: Sep 2023
First submitted: 18 May 2009
Last updated: 7 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Dharnidharka VR, Kwon C, Stevens G. Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis. Am J Kidney Dis. 2002 Aug;40(2):221-6. doi: 10.1053/ajkd.2002.34487.
PubMed 12148093
Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.
PubMed 9112351

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
RecruitingPhase 2/3
CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
Kidney Pancreas Transplantation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
Active, not recruiting
Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"
Renal Transplantation
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients

All Kidney Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optima: Optimizing Prograf Therapy in Maintenance Allografts II
ClinicalTrials.gov ID: NCT00905515
Acronym / sponsor ID: OPTIMAII / MR-06-001
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation, Immunosuppressive Agents
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: East Carolina UniversityUniversity, hospital or other
Collaborators: Astellas Pharma US, Inc.
Study start: Aug 2003
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 20 May 2009 (estimated)
Results: Posted 11 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study is designed to optimize calcineurin immunosuppressive regimens to ensure the best possible long-term outcomes after renal transplantation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control Group Cyclosporine	Active comparator	Drug: cyclosporineMaintain on Cyclosporine (CsA) at target trough level of 50-250 ng/mL.
Low Trough Level Prograf Group	Active comparator	Drug: Prograf (Tacrolimus)Convert to Prograf (TAC) at target trough levels of 3.0-5.9 ng/mL.
High Trough Level Prograf Group	Active comparator	Drug: Prograf (Tacrolimus)Convert to TAC at target trough levels of 6.0-8.9 ng/mL.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patient is the recipient of a cadervic or living donor renal transplant.
Patient was 18 years of age at time of transplant.
Patient is at least 6 months post-transplant.
Patient has been on a cyclosporine-based immunosuppressive regimen since the transplant.
Patient has a functioning allograft and a Cockcroft/Gault estimate of creatinine clearance >or= 35 mL/min within four weeks prior to randomization.

Key exclusion criteria (10 listed)

Patient is the recipient of a solid organ transplant other than the kidney.
Patient experienced biopsy-confirmed, acute rejection, (Banff 97 criteria)within 3 months before randomization that required treatment, which is defined as antilymphocyte therapy, corticosteroids, or an increase in the number or dose of immunosuppressant medication.
Patient has recurrence of primary renal disease, or de novo renal disease.
Patient has a urine protein of > 1.5g/24 hours or two successive urinalyses sent to and reported by the laboratory indicating albuminuria greater than 2+ within 6 months prior to enrollment.
Patient has an estimated creatinine clearance < 35 mL/min calculated using Cockcroft/Gault formula within four weeks prior to randomization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cyclosporineAlso: Cyclosporine/Neoral®/Sandimmune®/Gengraf®Maintain on cyclosporine at target trough level of 50-250 ng/mL.	Drug	Control Group Cyclosporine
Prograf (Tacrolimus)Also: Tacrolimus/Prograf®/FK506Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).	Drug	High Trough Level Prograf Group, Low Trough Level Prograf Group

Primary outcome

Renal Function in Patients Converted From Cyclosporine to Prograf
Time frame: 3 years
Optimal Dose of Calcineurin Inhibitor in Long-term Maintenance Kidney Transplant Patients
Time frame: 3 years
Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine
Time frame: 3 years

Results and safety

Results posted to the registry on 11 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remaining on CsA	21	19
Reduced TAC	20	20
Standard TAC	22	20

Primary outcome: Renal Function in Patients Converted From Cyclosporine to Prograf

Time frame: 3 years. Mean (Full Range). Unit: Change in serum creatinine (mg/dL)

Measure	Remaining on CsA n = 21	Reduced TAC n = 20	Standard TAC n = 22
Value	0.05 (-0.04 to 0.14)	0 (0 to 0)	0.10 (-0.07 to 0.26)

Primary outcome: Optimal Dose of Calcineurin Inhibitor in Long-term Maintenance Kidney Transplant Patients

Time frame: 3 years. Mean (Standard Deviation). Unit: ng/dL

Measure	Remaining on CsA n = 21	Reduced TAC n = 20	Standard TAC n = 22
Value	130.2 (54.94)	5.24 (2.06)	6.90 (2.06)

Primary outcome: Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine

Time frame: 3 years. Median (Standard Deviation). Unit: ng/dL

Measure	Remaining on CsA n = 21	Reduced TAC n = 20	Standard TAC n = 22
Value	4.75 (0.82)	4.72 (0.52)	4.89 (0.33)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remaining on CsA	0 of 21 (0%)	11 of 21 (52.4%)	Not reported
Reduced TAC	2 of 20 (10%)	14 of 20 (70%)	Not reported
Standard TAC	1 of 22 (4.5%)	14 of 22 (63.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12148093Dharnidharka VR, Kwon C, Stevens G. Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis. Am J Kidney Dis. 2002 Aug;40(2):221-6. doi: 10.1053/ajkd.2002.34487.
Background: PubMed 9112351Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.

Related trials for Kidney Transplantation

RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
RecruitingPhase 2/3
CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
Kidney Pancreas Transplantation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
Active, not recruiting
Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"
Renal Transplantation
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Bolin, MD principal investigator

East Carolina University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing cyclosporine and Prograf (Tacrolimus) in people with Kidney Transplantation, run by East Carolina University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Renal Function in Patients Converted From Cyclosporine to Prograf (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00905515, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.